aortic valve implant News
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JenaValve Technology Receives CE Mark for its Trilogy TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis
JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement) for the treatment of aortic valve disease, today announced that it has received CE Mark for its TrilogyTM Heart Valve System for the treatment of both aortic regurgitation (AR), also known as aortic ...
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Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System
Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that the Colibri transcatheter aortic valve implantation (TAVI) System has been used on an additional four patients in the ongoing international, single-arm, open-label early feasibility study (EFS). Initial post-implantation results from these patients, who received a 24mm valve, show favorable low aortic ...
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Colibri Heart Valve Advances Second-Generation TAVI System into Clinical Feasibility Study
Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that the first two patients have been successfully enrolled in a clinical early feasibility study (EFS) of the company’s disruptive second-generation ready-for-use balloon-expandable transcatheter aortic valve implantation (TAVI) system. As with Colibri’s earlier generation system, this TAVI ...
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Colibri Heart Valve Receives ISO 13485 and EN ISO 13485 Certification
Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announced today that it has received certification from DEKRA Certification B.V. that the company complies with the European requirements of ISO 13485 and EN ISO 13485 for a comprehensive quality management system for the design and manufacture of the company’s pre-packaged, ...
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JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial
JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk aortic regurgitation. Aortic regurgitation (AR) is a condition ...
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Colibri Heart Valve Receives European Patent for a Method of Making a Pre-packaged, Sterilized Dry Heart Valve, Pre-mounted on a Delivery Catheter
Colibri Heart Valve LLC, a privately held emerging medical device company, has received notification from the European Patent Office that patent application No. 11751242.6 titled, “Percutaneously Deliverable Heart Valve and Methods Associated Therewith” has been granted and is expected to publish as European Patent No. 2542184 (the “European Patent”) on May 25, 2016. This ...
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Colibri Heart Valve Strengthens Patent Portfolio with Receipt of 12th Transcatheter Heart Valve (THV) Patent
Colibri Heart Valve LLC, a privately held emerging medical device company, has received an Issue Notification from the U.S. Patent and Trademark Office regarding the forthcoming granting of U.S. Patent No. 9,125,739 (the “’739 Patent”) titled, “Percutaneous Replacement Heart Valve and a Delivery and Implantation System.” This will be Colibri’s 12th ...
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Colibri Heart Valve to Present Patient Follow-up Results from Clinical Feasibility Study of Second-Generation TAVI System at TCT
Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that results from the company’s international, single-arm, open-label early feasibility study (EFS) of the Colibri transcatheter aortic valve implantation (TAVI) system will be presented at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) annual meeting taking place September 21-25, 2018 ...
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JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System
JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe. The procedures, which included treatment of both aortic regurgitation1 (AR) and aortic stenosis1 (AS), took place in multiple centers in Germany, marks the official start of the ...
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CytoSorbents Appoints Daniel Wendt, MD, PhD, MHBA, FECTS as Vice President, Medical Affairs Cardiovascular
CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces the appointment of Professor Daniel Wendt, MD, PhD, MHBA, FETCS as Vice President, Medical Affairs Cardiovascular commencing January 1, 2022. Dr. Wendt is an internationally renowned academic cardiac surgeon with over ...
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Colibri Heart Valve Announces Issuance of a Patent for a Pre-mounted, Pre-packaged, Sterilized Dry Heart Valve on a Delivery System
Colibri Heart Valve, LLC, a privately held medical device company, has been granted yet another patent directed to prosthetic heart valves. More particularly, today the U.S. Patent & Trademark Office granted Colibri U.S. Patent No. 8,361,144 entitled, “Percutaneously Deliverable Heart Valve Device And Methods Associated Therewith.” The patent is directed to a method of making a ...
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Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart
Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. In conjunction with its formation, Colibri has granted Colorado Therapeutics a license to develop and market innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue ...
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Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart
Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. In conjunction with its formation, Colibri has granted Colorado Therapeutics a license to develop and market innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue ...
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BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices
BioStable Science & Engineering, Inc., a medical technology company focused on products for aortic valve repair for the treatment of aortic insufficiency, today announced that over 500 patients worldwide have now been treated using the HAART Aortic Annuloplasty Device. “Many cardiothoracic surgeons recognize that the young aortic insufficiency patient population cannot be treated with ...
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