transcatheter valve News
-
You live and learn
To better understand the needs of new medical markets, it has great importance for us to directly talk to end users. One of these end users is Prof. Reuthebuch who is Deputy Senior Physician of Cardiac Surgery in the university hospital in Basel. Together with him, we have evaluated in which part of a transcatheter heart valve implantation our navigation technology could provide benefits. This ...
-
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 ...
-
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 ...
-
BioTrace Medical Announces Key Events Featuring Tempo Temporary Pacing Lead at TVT 2019
BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced the company’s key activities at the Annual Transcatheter Valve Therapy Structural Heart Summit (TVT 2019), which will take place June 12-15 at the Sheraton Grand Chicago. The company’s Tempo Temporary Pacing Lead will be featured in a symposium titled “Improving Safety & Reducing ...
-
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, ...
-
BioTrace Medical Announces Key Events Featuring Tempo Temporary Pacing Lead at TCT 2017
BioTrace Medical, Inc., today announced the company’s key activities at the Transcatheter Cardiovascular Therapeutics (TCT) 2017 meeting, which will take place October 29 - November 2 at the Colorado Convention Center in Denver. The company’s Tempo Temporary Pacing Lead will be featured in a breakfast symposium titled: “The Tempo Temporary Pacing Lead: A New Standard of Care in ...
-
JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality
JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf toVice President, Regulatory Affairs and Quality, effective immediately. Ms. Metcalf comes to JenaValve with over 30 years of experience in themedical device industry ...
-
BlueWind Medical Appoints Dan Lemaitre as Chief Executive Officer
BlueWind Medical, developer of the RENOVA iStim, an innovative, leadless, miniature neurostimulation platform initially being developed for the treatment of Over Active Bladder (OAB), announced the appointment of Daniel T. Lemaitre as Chief Executive Officer (CEO) effective January 1st, 2020. Mr. Lemaitre has served as Chairman of the Board of BlueWind Medical since November 2018. Lemaitre is ...
-
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 ...
-
iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients
iRhythm Technologies has presented new data on its Zio wearable cardiac monitoring device at the American College of Cardiology (ACC) 71st Annual Scientific Session & Expo, building the clinical case for its devices. One study used Zio AT for monitoring patients who were taken to hospital after fainting. By using the device to monitor patients after discharge, the physicians reduced ...
-
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 ...
-
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 ...
-
JenaValve Technology Closes $50 Million Financing
JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease, announces that it has raised $50 million in an equity financing led by Bain Capital Life Sciences. Additional participants in the financing included existing investors Andera Partners, Gimv, Legend Capital, NeoMed ...
-
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 ...
-
JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited
JenaValve Technology, Inc. (“JenaValve” or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited (HKEX: 9996) in China. Under the terms of the agreement, Peijia has made a cash and equity investment in ...
-
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 ...
-
Saranas Recognized as One of Houston’s Most Innovative Companies
Saranas Inc., a medical device company pioneering technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been named one of Houston’s most innovative companies. Saranas is the only medical device company to be honored at the inaugural Innovation Awards presentation sponsored by the Houston Business Journal on ...
-
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 ...
-
Safety and Effectiveness of BioTrace Medical’s Tempo® Lead Further Demonstrated in Multi-Center Analysis of More Than 200 Cardiac Procedures
BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced positive safety and effectiveness data from a physician-sponsored U.S. study of the company’s Tempo Temporary Pacing Lead. Results from a multi-center retrospective analysis of 224 U.S. interventional cardiac procedures, including transcatheter aortic valve replacement (TAVR), confirm the Tempo ...
-
CorWave Attracts Global Talent, Strengthening Its Management Team in Preparation for Clinical Phase and Industrial Ramp Up
CorWave, a French medtech developing a next-generation heart pump, is recruiting top talent from throughout the world to strengthen its team. Two seasoned industry experts are joining the company: Paul Cornelison (USA) as Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs, and Michael Webb (Australia) as Vice President, Manufacturing. Paul Cornelison and Michael Webb have ...
By CorWave
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you