News

The U.S. Food and Drug Administration (FDA) approved the Sorin Freedom Solo and Solo Smart stentless heart valves from Sorin Group Canada Inc. to replace a diseased, damaged or malfunctioning...

Cardiothoracic and Vascular Surgeons became the first in Texas to implant the Solo Smart Aortic Pericardial Heart Valve. Faraz Kerendi, M.D. and Stephen J. Dewan M.D., performed the procedure at...

Neovasc Inc. has received conditional Investigational Device Exemption (IDE) approval from the U.S. FDA to initiate the U.S. arm of its Tiara-I Early Feasibility Trial for the company's Tiara...

October 10, 2014—Mitralign Inc. reported on the successful use of its technology to perform a percutaneous repair on a patient with tricuspid regurgitation (TR). Prof. Dr. med. J. Schofer of the...

Direct Flow Medical Inc., a transcatheter heart valve innovator focused on improving patient outcomes has received the CE Mark for an enhanced transfemoral delivery system for the ...

Claret Medical announced the first patient has been successfully treated in its SENTINEL trial, a multicenter pivotal trial of the Sentinel cerebral protection system (CPS). The landmark trial is...

Occlutech CE mark Dedicated Paravalvular Leak Closure Device

Occlutech  announced that it has obtained a European CE mark approval for its dedicated Paravalvular Leak Closure Device (PLD).

Claret Medical, Sentinel

While transcatheter aortic valve replacement (TAVR) is a paradigm shift in how valve disease is treated, one nagging safety issue that remains is TAVR’s stroke rate, which is higher than...

trinity, transcatheter technologies

Transcatheter Technologies GmbH has announced that results of a first-in-human clinical study of its TRINITY system have been published ahead of print publication in the July issue of the peer-...

Two-Year Results CoreValve U.S. Pivotal Trial TCT 2014

In extended follow-up from the CoreValve U.S. Pivotal Trial, the self-expanding transcatheter aortic valve was shown to have low rates of all-cause mortality and major stroke. Findings were...

September 22, 2014 — A first-of-its kind study found that using a cerebral protection device during transcatheter aortic valve replacement (TAVR) can significantly reduce the number and volume of...

U.S. CoreValve High Risk trial TCT 2014

According to a new study, transcatheter aortic valve replacement (TAVR) provided meaningful clinical benefits relative to surgical aortic valve replacement (SAVR) in high risk patients with...

PARTNER I Trial TCT 2014 TAVR Heart Valve Repair

New data from a landmark clinical trial found that after five years, transcatheter aortic valve replacement (TAVR) demonstrated a persistent mortality benefit, improved functional status, and...

St. Jude Medical Portico TAVR System Minneapolis Heart Institute Implant Trial

The Minneapolis Heart Institute Foundation (MHIF) announced its first implant of the Portico Re-sheathable Transcatheter Aortic Valve System, developed by St. Jude Medical. 

Claret Medical Cerebral Protection Series B Financing Sentinel CPS System

Claret Medical Inc. announced that it has entered into an agreement for up to $18 million in a Series B financing. The Series B round was led by Santé Ventures, a prominent healthcare-focused...

Medtronic U.S. Implants Clinical Study Recapturable CoreValve Evolut R

Medtronic Inc. announced the first U.S. implants in the CoreValve Evolut R Clinical Study, which will evaluate  the safety and effectiveness of the new Medtronic CoreValve Evolut R System.

Claret Medical Sentinel Cerebral Protection System Celebral Protection

Claret Medical Inc. vascular and cardiac surgery procedures, announced that it has entered into an agreement for up to $18 million in a Series B financing.

September 4, 2014 — Medtronic announced CE mark for the 23 mm CoreValve Evolut R system for transcatheter aortic valve implantation (TAVI). The novel self-expanding valve and 14 French equivalent...

heart valve, heart surgery

For the first time in the United States, doctors at Henry Ford Hospital used a minimally invasive procedure to replace a failing, hard-to-reach heart valve with a new one – and placed it just...

August 29, 2014 — Direct Flow Medical announced it received CE mark for a 23 mm valve as part of its Direct Flow Medical transcatheter aortic valve system, expanding the patient population...