aortic valve News
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BioStable Science & Engineering Announces CE Mark Approval for the HAART 200 Aortic Annuloplasty Device & Surpasses 1,000 Patients Treated Worldwide with the HAART Devices
BioStable Science & Engineering, Inc., (“BioStable”) announced today the company has received CE Mark approval for the HAART 200 Aortic Annuloplasty Device for use during bicuspid aortic valve repair. With CE Mark approval of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable will be able to offer surgeons within the European Union a comprehensive portfolio of ...
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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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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 ...
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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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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 ...
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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 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 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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Five TAVR Patients Successfully Implanted with DurAVR Valve
Anteris reports successfully implanting five TAVR patients during the week of 14 November 2021 in a first-in-human (FIH) study to assess the DurAVR THV system for treating severe aortic stenosis. The study was carried out at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia. The transcatheter aortic valve replacement procedures for all five patients were successful and without any ...
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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 ...
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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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DurAVR accepted into TCT innovation session
Anteris Technologies Ltd (ASX: AVR) (Anteris or the Company) announces its submission at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference at Orlando, Florida, United States was accepted into the innovation session. The TCT conference, running from November 4 to 6, is the largest and most prestigious Interventional cardiology meeting held each year and will return to ...
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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 ...
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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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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 ...
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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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Anteris reports successful interim results for the first-in-human trial for DurAVR
Anteris Technologies Ltd (ASX: AVR) reports the first-in-human DurAVR™ THV study met or exceeded its interim study objectives. At the 30-day follow up point, the first five patients of the planned 10-patient study showed: All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention). An average 86% improvement in mean ...
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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 ...
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BIOMODEX and Montreal Heart Institute Team Up to Develop 3D Printed Pulsatile Heart Models
BIOMODEX®, the leader in biorealistic haptic simulators for physician training and rehearsals, and the Montreal Heart Institute (MHI), a world-renowned, ultra-specialized cardiology center, announced they are partnering to develop a new cardiovascular training solution to help cardiologists rehearse and train for complex valve-in-valve procedures. The teams will collaborate to develop ...
By BIOMODEX
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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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