Aortic Implant Articles & Analysis
14 news found
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. ...
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. ...
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 ...
In the early 1990s we developed the first stent graft that could be delivered with the percutaneous entry for repairing aortic aneurysms. In 1995 in Australia we completed the first non-surgical repair of an aortic aneurysm. ...
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. ...
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 ...
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, ...
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 ...
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 ...
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, ...
Colibri has developed a pre-mounted, pre-crimped, and pre-packaged, ready-for-use transcatheter aortic valve implantation (TAVI) device called the “Colibri TAVI ...
The Colibri TAVI System has been successfully tested in a first-in-human study in patients with severe symptomatic aortic valve stenosis who are deemed very high risk for open-heart valve replacement surgery. Study participants have been followed for more than three years and have demonstrated consistent positive outcomes, including no observed stroke, no pacemaker ...
The Colibri TAVI System has been successfully tested in a first-in-human study in patients with severe symptomatic aortic valve stenosis who are deemed very high risk for open-heart valve replacement surgery. Study participants have been followed for more than three years and have demonstrated consistent positive outcomes, including no observed stroke, no pacemaker ...
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 allowed/granted patent and will issue on September 8, 2015. ...