{"id":42662,"date":"2021-04-29T10:43:51","date_gmt":"2021-04-29T14:43:51","guid":{"rendered":"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/?p=81"},"modified":"2022-04-13T10:07:48","modified_gmt":"2022-04-13T14:07:48","slug":"ortho-1","status":"publish","type":"post","link":"https:\/\/www.hajim.rochester.edu\/senior-design-day\/ortho-1\/","title":{"rendered":"Portico Health"},"content":{"rendered":"\n<h2 class=\"has-text-align-center wp-block-heading\">Team and Specialty<\/h2>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\n<div class=\"wp-block-group alignfull\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-coblocks-gallery-masonry alignfull\"><div class=\"coblocks-gallery has-caption-style-dark has-gutter\"><ul class=\"has-grid-lrg has-gutter-15\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/aaron.png\" alt=\"\" data-id=\"189\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/?attachment_id=189\" class=\"wp-image-189\"\/><figcaption class=\"coblocks-gallery--caption\">Aaron Craig<\/figcaption><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/meg.png\" alt=\"\" data-id=\"190\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/?attachment_id=190\" class=\"wp-image-190\"\/><figcaption class=\"coblocks-gallery--caption\">Meg Luzenski<\/figcaption><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/alex.png\" alt=\"\" data-id=\"191\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/?attachment_id=191\" class=\"wp-image-191\"\/><figcaption class=\"coblocks-gallery--caption\">Alex McMullen<\/figcaption><\/figure><\/li><\/ul><\/div><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p>Our team consists of Aaron Craig, Meg Luzenski, and Alex McMullen. We completed our clinical observations in the Orthopaedic Surgery department at the University of Rochester Medical Center (URMC).<\/p>\n\n\n\n<p>Kaia Williams, a TEAM student, also joined the group to assist with our business plan. With Kaia&#8217;s help, our team made it to the semi-finals of the Mark Ain Business Plan competition.<\/p>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\">Medical Condition<\/h2>\n\n\n\n<div class=\"wp-block-coblocks-gallery-stacked aligncenter mb-0 mt-0\"><ul class=\"coblocks-gallery\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-bottom-mobile-15\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Cervical-spinal-stenosis-1.jpg\" alt=\"\" data-id=\"471\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/cervical-spinal-stenosis-1\/\" class=\"wp-image-471 has-shadow-none\"\/><figcaption class=\"coblocks-gallery--caption\"><span class=\"has-inline-color has-primary-color\">Source: https:\/\/discectomy.net\/wp-content\/uploads\/2018\/09\/Cervical-spinal-stenosis.jpg<\/span><\/figcaption><\/figure><\/li><\/ul><\/div>\n\n\n\n<p class=\"has-text-align-left has-normal-font-size\">Cervical spinal stenosis is a painful, and potentially debilitating, narrowing of the spinal canal. In patients whose spinal stenosis is a result of cervical&nbsp;spondylitic&nbsp;myelopathy (CSM) or ossification of the posterior longitudinal ligament (OPLL) [1][2], an open-door laminoplasty procedure is a possible treatment option.<\/p>\n\n\n\n<p class=\"has-normal-font-size\">An open-door laminoplasty opens the laminae of cervical vertebrae to expand the spinal canal and decompress the spinal cord. When compared to Laminectomy or Anterior Cervical Discectomy and Fusion, laminoplasty has been shown to have lower complication rates and greater range of motion preservation [3][4][5]. <\/p>\n\n\n\n<div class=\"wp-block-coblocks-gallery-stacked aligncenter mb-0 mt-0\"><ul class=\"coblocks-gallery has-fullwidth-images\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-bottom-mobile-15\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"277\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/laminoplasty1-1-1024x277.jpg\" alt=\"\" data-id=\"479\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/laminoplasty1-1\/\" class=\"wp-image-479 has-shadow-none\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/laminoplasty1-1-1024x277.jpg 1024w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/laminoplasty1-1-300x81.jpg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/laminoplasty1-1-768x208.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/laminoplasty1-1.jpg 1040w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"coblocks-gallery--caption\"><span class=\"has-inline-color has-primary-color\">Source: adapted from the DePuy Synthes ARCH FIXATION SYSTEM surgical brochure<\/span><\/figcaption><\/figure><\/li><\/ul><\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Surgical Difficulty\/Problem<\/strong><\/h2>\n\n\n\n<p>Currently available laminoplasty implant systems utilize 3 to 6 screws that are small and difficult to use.&nbsp;The size of these screws lends themselves to being dropped, posing a significant risk to sterility and patient safety.<\/p>\n\n\n\n<p>These factors make an already challenging procedure more difficult, steering some surgeons away from the procedure altogether, despite the proven benefits to patients over laminectomies such as improved range of motion and reduced recovery time.<\/p>\n\n\n\n<p class=\"has-normal-font-size\">The current devices on the market all possess extremely similar design characteristics with little innovation over the past two decades. Some examples of current laminoplasty implants are shown below:<\/p>\n\n\n\n<div class=\"wp-block-coblocks-gallery-carousel mb-0 mt-0\"><div class=\"is-cropped coblocks-gallery has-no-alignment has-caption-style-dark has-horizontal-gutter\"><div class=\"has-carousel has-carousel-lrg has-aligned-cells\" style=\"height:385px\" data-flickity=\"{&quot;autoPlay&quot;:2000,&quot;draggable&quot;:true,&quot;pageDots&quot;:false,&quot;prevNextButtons&quot;:true,&quot;wrapAround&quot;:true,&quot;cellAlign&quot;:&quot;left&quot;,&quot;pauseAutoPlayOnHover&quot;:true,&quot;freeScroll&quot;:false,&quot;arrowShape&quot;:{&quot;x0&quot;:10,&quot;x1&quot;:60,&quot;y1&quot;:50,&quot;x2&quot;:65,&quot;y2&quot;:45,&quot;x3&quot;:20},&quot;thumbnails&quot;:false,&quot;responsiveHeight&quot;:false}\"><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"353\" height=\"388\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate2-2.png\" alt=\"\" data-id=\"494\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/plate2-2\/\" class=\"wp-image-494\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate2-2.png 353w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate2-2-273x300.png 273w\" sizes=\"auto, (max-width: 353px) 100vw, 353px\" \/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate4-1.png\" alt=\"\" data-id=\"495\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/plate4-1\/\" class=\"wp-image-495\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate5-1.png\" alt=\"\" data-id=\"496\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/plate5-1\/\" class=\"wp-image-496\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate6-1.png\" alt=\"\" data-id=\"497\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/plate6-1\/\" class=\"wp-image-497\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate7.png\" alt=\"\" data-id=\"498\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/plate7\/\" class=\"wp-image-498\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/plate8.png\" alt=\"\" data-id=\"499\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/plate8\/\" class=\"wp-image-499\"\/><\/figure><\/div><\/div><\/div><figcaption class=\"coblocks-gallery--caption coblocks-gallery--primary-caption\"><span class=\"has-inline-color has-primary-color\">Plates included in images: Globus CANOPY, Zimmer Biomet Gallery, Stryker Elevate, Seaspine Laminoplasty System, ChoiceSpine Blackbird HLS, and Xtant Medical Xspan (not in specific order)<\/span><\/figcaption><\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Market Opportunity<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-coblocks-gallery-stacked aligncenter mb-0 mt-0\"><ul class=\"coblocks-gallery has-fullwidth-images\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-bottom-mobile-15\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/market-2.png\" alt=\"\" data-id=\"503\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/market-2-2\/\" class=\"wp-image-503 has-shadow-none\"\/><figcaption class=\"coblocks-gallery--caption\"><span class=\"has-inline-color has-primary-color\">Source: from Portico Health business pitch slide deck [6]<\/span><\/figcaption><\/figure><\/li><\/ul><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"has-normal-font-size\">Our market and sales strategy starts by engaging with surgeons that currently perform laminoplasties in the Rochester, NY region. We have estimated a total addressable market (TAM) of $450,000 in this region.<\/p>\n\n\n\n<p class=\"has-normal-font-size\">Our company believes that by creating a system that greatly simplifies the laminoplasty procedure we will not only be a part of the laminoplasty market but capture a portion of the laminectomy market as well, which could expand the available market by up to $105 million in the United States and $360 million globally. <\/p>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>BioDesign Statement<\/strong><\/h2>\n\n\n\n<p>A way to eliminate the need for multiple bone screws during an open-door laminoplasty to make the fixation process more usable for spine surgeons.<\/p>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Major Design Requirements<\/strong><\/h2>\n\n\n\n<p>Our team has started documenting design requirements that will be used for eventual Design Verification &amp; Validation (V&amp;V) activities. Below are some of the critical requirements that we have identified:<\/p>\n\n\n\n<div class=\"wp-block-coblocks-accordion\">\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Functional &#8211; Implant Fixation<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The plate and fastener must remain fixated in the state they were in when they were implanted during the surgery.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Compatibility &#8211; Implant Material<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The implant material must be nonreactive with the patient.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">User Interface &#8211; Instrument Alignment<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The drill guide and spacer must align concentrically.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Functional &#8211; Fastener Migration<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Fastener remains in site of implantation after surgery and does not migrate.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Functional &#8211; Implant Mechanical Strength<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Spacer and fastener can withstand forces experienced during daily activities of patients.<\/p>\n<\/div><\/details><\/div>\n<\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Prototypes<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-coblocks-gallery-stacked aligncenter mb-0 mt-0\"><ul class=\"coblocks-gallery has-fullwidth-images\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-bottom-mobile-15\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"275\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/proto3-1024x275.png\" alt=\"\" data-id=\"519\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/proto3\/\" class=\"wp-image-519 has-shadow-none\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/proto3-1024x275.png 1024w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/proto3-300x81.png 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/proto3-768x207.png 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/proto3-1200x323.png 1200w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/proto3.png 1528w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/li><\/ul><\/div>\n\n\n\n<p>Our team was able to complete a first-iteration, proof-of-concept prototype to demonstrate our idea. This prototype includes working 3D printed models of the most common spacer implant size (10mm functional length) and a drill guide. A standard, off-the-shelf machine screw with the correct length and diameter is used for the physical prototype, but initial 3D models have been generated for the proposed fastener implant. <\/p>\n\n\n\n<p>The images below illustrate how our system works:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\n<figure class=\"wp-block-gallery columns-3 is-cropped mb-0 mt-0 wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\"><ul class=\"blocks-gallery-grid\"><li class=\"blocks-gallery-item\"><figure><img loading=\"lazy\" decoding=\"async\" width=\"304\" height=\"418\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/proto4.png\" alt=\"\" data-id=\"520\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/proto4\/\" class=\"wp-image-520\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/proto4.png 304w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/proto4-218x300.png 218w\" sizes=\"auto, (max-width: 304px) 100vw, 304px\" \/><\/figure><\/li><li class=\"blocks-gallery-item\"><figure><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/proto5.png\" alt=\"\" data-id=\"521\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/proto5\/\" class=\"wp-image-521\"\/><\/figure><\/li><li class=\"blocks-gallery-item\"><figure><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/proto6.png\" alt=\"\" data-id=\"522\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/proto6\/\" class=\"wp-image-522\"\/><\/figure><\/li><li class=\"blocks-gallery-item\"><figure><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/proto7.png\" alt=\"\" data-id=\"523\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/proto7\/\" class=\"wp-image-523\"\/><\/figure><\/li><li class=\"blocks-gallery-item\"><figure><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/proto8.png\" alt=\"\" data-id=\"524\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/proto8\/\" class=\"wp-image-524\"\/><\/figure><\/li><\/ul><\/figure>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Testing<\/strong><\/h2>\n\n\n\n<p>Proof-of-concept testing has been completed for the first iteration prototype, using the 3D printed implant\/instrument models and our custom-built laminoplasty test platform. <\/p>\n\n\n\n<div class=\"wp-block-coblocks-gallery-carousel\"><div class=\"is-cropped coblocks-gallery has-no-alignment has-caption-style-dark has-horizontal-gutter\"><div class=\"has-carousel has-carousel-lrg\" style=\"height:400px\" data-flickity=\"{&quot;autoPlay&quot;:false,&quot;draggable&quot;:true,&quot;pageDots&quot;:false,&quot;prevNextButtons&quot;:true,&quot;wrapAround&quot;:true,&quot;cellAlign&quot;:&quot;center&quot;,&quot;pauseAutoPlayOnHover&quot;:false,&quot;freeScroll&quot;:false,&quot;arrowShape&quot;:{&quot;x0&quot;:10,&quot;x1&quot;:60,&quot;y1&quot;:50,&quot;x2&quot;:65,&quot;y2&quot;:45,&quot;x3&quot;:20},&quot;thumbnails&quot;:false,&quot;responsiveHeight&quot;:false}\"><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test1-768x1024.jpg\" alt=\"\" data-id=\"531\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test1\/\" class=\"wp-image-531\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/test2-768x1024.jpg\" alt=\"\" data-id=\"547\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test2-2\/\" class=\"wp-image-547\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/test2-768x1024.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/test2-225x300.jpg 225w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/test2.jpg 960w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure 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has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test5-768x1024.jpg\" alt=\"\" data-id=\"535\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test5\/\" class=\"wp-image-535\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test5-768x1024.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test5-225x300.jpg 225w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test5.jpg 960w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test6-768x1024.jpg\" alt=\"\" data-id=\"536\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test6\/\" class=\"wp-image-536\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test7-768x1024.jpg\" alt=\"\" data-id=\"537\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test7\/\" class=\"wp-image-537\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test7-768x1024.jpg 768w, 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src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test9-768x1024.jpg\" alt=\"\" data-id=\"539\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test9\/\" class=\"wp-image-539\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test10-768x1024.jpg\" alt=\"\" data-id=\"540\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test10\/\" class=\"wp-image-540\"\/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test11-768x1024.jpg\" alt=\"\" data-id=\"541\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test11\/\" class=\"wp-image-541\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test11-768x1024.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test11-225x300.jpg 225w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test11.jpg 960w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test12-768x1024.jpg\" alt=\"\" data-id=\"542\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test12\/\" class=\"wp-image-542\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test12-768x1024.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test12-225x300.jpg 225w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test12.jpg 960w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test13-768x1024.jpg\" alt=\"\" data-id=\"543\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test13\/\" class=\"wp-image-543\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test13-768x1024.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test13-225x300.jpg 225w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test13.jpg 960w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test14-768x1024.jpg\" alt=\"\" data-id=\"544\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test14\/\" class=\"wp-image-544\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test14-768x1024.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test14-225x300.jpg 225w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test14.jpg 960w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure><\/div><div class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure has-margin-left-5 has-margin-left-mobile-5 has-margin-right-5 has-margin-right-mobile-5\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1024\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test15-768x1024.jpg\" alt=\"\" data-id=\"545\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/cmti21\/uncategorized\/ortho-1\/attachment\/test15\/\" class=\"wp-image-545\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test15-768x1024.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test15-225x300.jpg 225w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/test15.jpg 960w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure><\/div><\/div><\/div><\/div>\n\n\n\n<p>Future testing would include screw pull-out force, spacer compression strength, and quantification of decompression in the vertebral foramen.<\/p>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Regulatory Strategy<\/strong><\/h2>\n\n\n\n<p>Based on pre-existing regulatory framework for current laminoplasty implants, we have determined that the Portico Laminoplasty System falls into the following classification:<\/p>\n\n\n\n<p>Product Code: NQW<\/p>\n\n\n\n<p>Regulation Number: 888.3050 (Spinal&nbsp;Interlaminal&nbsp;Fixation Orthosis)<\/p>\n\n\n\n<p>Class: II<\/p>\n\n\n\n<p>Therefore, we propose that the regulatory pathway for this device will be through 510(k) clearance. This will require evidence of substantial equivalence to a predicate device, primarily through engineering benchtop testing. The device will have to follow general and special controls once cleared.<\/p>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Conclusions<\/strong><\/h2>\n\n\n\n<p>There is a clear need for innovation in the cervical laminoplasty space. The procedure offers a variety of benefits, yet some surgeons avoid it because of &#8220;finicky&#8221; and frustrating implants. Our team believes that we have developed a novel implant system that makes open-door laminoplasty more approachable. Further work needs to be completed to refine the design and conduct appropriate testing to ensure this device is safe and effective. <\/p>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>Acknowledgments<\/strong><\/h2>\n\n\n\n<p>We would like to thank our fantastic team of mentors and clinical collaborators for their guidance and contributions to this project:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Greg Gdowski, PhD<\/li><li>Martin Gira<\/li><li>Mary Maida, PhD<\/li><li>Addisu Mesfin, MD<\/li><li>Howard Silberstein, MD<\/li><li>Shalin Shah, MD<\/li><li>Jonathan Stone, MD<\/li><\/ul>\n\n\n\n<p>We would also like to thank the CMTI program and the University of Rochester Biomedical Engineering department for giving us this opportunity.<\/p>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\"><strong>References<\/strong><\/h2>\n\n\n\n<p class=\"has-small-font-size\">[1] Steinmetz, M., &amp; Resnick, D. (2006). Cervical Laminoplasty. The Spine Journal, 6(6), S274\u2013S281.&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/doi.org\/10.1016\/j.spinee.2006.04.023\" target=\"_blank\">https:\/\/doi.org\/10.1016\/j.spinee.2006.04.023<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\">[2] Shimer, A., Lee, J., &amp;&nbsp;Tannoury, C. (2007). Operative Techniques in&nbsp;Orthopaedics. Laminoplasty, 17(3), 169\u2013173.&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/doi.org\/10.1053\/j.oto.2007.04.003\" target=\"_blank\">https:\/\/doi.org\/10.1053\/j.oto.2007.04.003<\/a>&nbsp;<\/p>\n\n\n\n<p class=\"has-small-font-size\">[3] Adogwa, O., Huang, K., Hazzard, M.,&nbsp;Chagoya, G., Owens, R., Cheng, J.,&nbsp;Ugiliweneza, B., Boakye, M., &amp; Lad, S. P. (2015). Outcomes after cervical laminectomy with instrumented fusion versus expansile laminoplasty: A propensity matched study of 3185 patients. Journal of Clinical Neuroscience, 22(3), 549\u2013553.&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/doi.org\/10.1016\/j.jocn.2014.10.001\" target=\"_blank\">https:\/\/doi.org\/10.1016\/j.jocn.2014.10.001<\/a>&nbsp;<\/p>\n\n\n\n<p class=\"has-small-font-size\">[4] Wang, M., Yokoyama, T.,&nbsp;Numasawa, T.,&nbsp;Toh, S., McGrady, L., &amp; Toth, J. (2006). P121. Biomechanical Evaluation of a Modified Cervical Laminoplasty. The Spine Journal, 6(5), 141S-142S.&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/doi.org\/10.1016\/j.spinee.2006.06.330\" target=\"_blank\">https:\/\/doi.org\/10.1016\/j.spinee.2006.06.330<\/a>&nbsp;<\/p>\n\n\n\n<p class=\"has-small-font-size\">[5] Hale, J. J.,&nbsp;Gruson, K. I., &amp; Spivak, J. M. (2006). Laminoplasty: a review of its role in compressive cervical myelopathy. The Spine Journal, 6(6), S289\u2013S298.&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/doi.org\/10.1016\/j.spinee.2005.12.032\" target=\"_blank\">https:\/\/doi.org\/10.1016\/j.spinee.2005.12.032<\/a>&nbsp;<\/p>\n\n\n\n<p class=\"has-small-font-size\">[6] Williams, K. (2021, April). <em>Portico Health Business Plan<\/em>. Mark Ain Business Plan Competition. Rochester, New York.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Portico Laminoplasty Fixation System allows surgeons to perform open-door laminoplasty using only one fastener.<\/p>\n","protected":false},"author":6242,"featured_media":62042,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"templates\/template-full-width.php","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[86,2946],"tags":[8732,8632],"coauthors":[8612],"class_list":["post-42662","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmti-archive","category-medical-archive","tag-implant","tag-spine-surgery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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