{"id":49939,"date":"2022-10-21T22:02:28","date_gmt":"2022-10-21T20:02:28","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/thubrikar-aortic-valve-completes-initial-ce-mark-enabling-tavi-1-study\/"},"modified":"2022-10-21T22:02:28","modified_gmt":"2022-10-21T20:02:28","slug":"thubrikar-aortic-valve-completes-initial-ce-mark-enabling-tavi-1-study","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/thubrikar-aortic-valve-completes-initial-ce-mark-enabling-tavi-1-study\/","title":{"rendered":"Thubrikar Aortic Valve completes initial CE Mark-enabling TAVI-1 Study"},"content":{"rendered":"
\n

NORRISTOWN, Pa.–(BUSINESS WIRE)–Thubrikar Aortic Valve, Inc., announced today that it has completed the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV\u2122) in patients with severe aortic stenosis. The implantations were performed by the Principal Investigator Jaroslaw Trebacz, M.D., at the Specialty Hospital Jana Pawla II, Krakow, Poland. The 5-patient study was approved by the Competent Authority of Poland, conducted in accordance with EU MDR, and monitored by the Company\u2019s CRO, KCRI.\n<\/p>\n

<\/a><\/p>\n

\nValve performance has been outstanding, with single digit mean gradients and EOAs better than most commercially available TAVR valves. \u201cWith over 14 years of my personal TAVR experience with all CE-marked devices, I now start to believe that Optimum TAV has the potential to combine the advantages of both a balloon- and a self-expandable valve,\u201d commented Dr. Trebacz.<\/b>\n<\/p>\n

\nOptimum TAV is the only short-profile, self-expanding TAV in its field, thus providing easy coronary access as well as the benefits of a self-expanding valve. It is designed to mimic the natural aortic valve with dimensional proportionality and leaflet surface geometry, no suture holes in the flexion zone of the leaflet, and a unique anti-calcification treatment.\n<\/p>\n

\nOptimum TAV has shown pre-clinical durability up to 24 years, with less calcification than established bioprosthetic surgical heart valves. Optimum TAV is intended to meet the needs of a younger patient population requiring a long-lasting valve with excellent hemodynamic performance. In Brazil, the first patient implanted with Optimum TAV continues to do well at 4 years.\n<\/p>\n

\n\u201cWe are delighted with these initial results at 1-month and 6-month outcomes. These were truly \u2018real world\u2019 patients including those with horizontal aorta, eccentric or no calcium burden, and small aortic annulus. The unique short frame and self-expanding technology of the Optimum TAV performed very well in these complex group of patients, and we look forward to expanding enrollment throughout Europe to obtain CE Mark approval,\u201d said Dr. Mano Thubrikar, Optimum TAV\u2019s inventor, and the Company\u2019s President and Founder. From the Company, Vishal Thubrikar, M.D., Ali Recber, Evan Roush, were also present for the study.\n<\/p>\n

\nDr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian\/Columbia University Medical Center, and Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health in the U.S. are long-standing advisors and trial consultants for the Company, including the development of its 2nd<\/sup>-generation delivery catheter – the PRECISION 2\u2122 CATHETER – which will provide repositionability and retrievability to the Optimum TAV, further optimizing the valve\u2019s long-term success. Drs. Williams and Kodali report disclosures with Thubrikar Aortic Valve, Inc.\n<\/p>\n

\nAbout Thubrikar Aortic Valve and its Optimum TAVI System<\/b>\u2122<\/b>\n<\/p>\n

\nThubrikar Aortic Valve, Inc. is a privately held medical device company near Philadelphia, PA, that has developed a next-generation transcatheter aortic valve, the Optimum TAV, and delivery catheter, collectively called the \u201cOptimum TAVI System.\u201d Optimum TAV was designed after the natural aortic valve using 30 years of research by the Company\u2019s Founder, Dr. Mano Thubrikar. He served as Director of Surgical Research at the University of Virginia, Director of Biomedical Engineering at the Heineman Medical Research Foundation in Charlotte, Distinguished Research Scientist at Edwards Lifesciences, and Director of Biomedical Engineering at the South Dakota School of Mines and Technology. He is the author of \u201cThe Aortic Valve,\u201d a leading textbook covering the fundamentals of valve structure and function. For more information, please visit: www.tavi.us<\/a>.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nThubrikar Aortic Valve
\n
Samir Wadke, Vice President of Business Development
\n
610-630-8284
\n
Samir.Wadke@tavi.us<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

NORRISTOWN, Pa.–(BUSINESS WIRE)–Thubrikar Aortic Valve, Inc., announced today that it has completed the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV\u2122) in patients with severe aortic stenosis. The implantations were performed by the Principal Investigator Jaroslaw Trebacz, M.D., at the Specialty Hospital Jana Pawla II, Krakow, Poland. The 5-patient study was … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-49939","6":"format-standard","7":"category-industry"},"yoast_head":"\nThubrikar Aortic Valve completes initial CE Mark-enabling TAVI-1 Study - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/thubrikar-aortic-valve-completes-initial-ce-mark-enabling-tavi-1-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Thubrikar Aortic Valve completes initial CE Mark-enabling TAVI-1 Study - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"NORRISTOWN, Pa.–(BUSINESS WIRE)–Thubrikar Aortic Valve, Inc., announced today that it has completed the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV\u2122) in patients with severe aortic stenosis. 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