News | May 12, 2015

FDA Grants IDE Approval for CardiAQ’s Transcatheter Mitral Valve Feasibility Study

Novel treatment offers transfemoral and transapical implantation options

CardiAQ, TMVI, FDA, IDE, feasibility study, mitral valve, Beth Israel Deaconess

May 12, 2015 — CardiAQ Valve Technologies announced U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for a feasibility study of its second generation transfemoral (TF) and transapical (TA) transcatheter mitral valve implantation systems. The study will enroll up to 20 patients (10 TF and 10 TA) and multidisciplinary physician teams at select U.S. sites will start enrollment once hospital approvals and agreements are in place. 

CardiAQ also announced that Beth Israel Deaconess Imaging Core Laboratory will serve as the core lab for its United States and outside the United States (OUS) studies. Jeffrey Popma, M.D., director, interventional cardiology, Beth Israel Deaconess Medical Center and professor of medicine, Harvard Medical School, will lead the trial.

The company’s proprietary transcatheter mitral valve implant can be delivered through multiple delivery systems, including both transfemoral and transapical. The system features a unique anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, allowing physicians to accurately and securely implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery.

The CardiAQ TMVI procedures are designed to be performed in a cardiac catheterization laboratory or hybrid operating room. Ultimately, the procedure will result in less trauma to the patient and substantial potential cost-savings to the healthcare system.

For more information: www.cardiaq.com

Related Content

Ancora Heart Announces Positive Interim Analysis of AccuCinch Ventricular Repair System for Heart Failure
News | Heart Valve Technology | September 24, 2018
Ancora Heart Inc. announced positive clinical data from the company’s recently expanded U.S. early feasibility study...
Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Gore Acquires Pipeline Medical Technologies Inc.
News | Heart Valve Technology | September 06, 2018
W. L. Gore & Associates Inc. (Gore) announced the acquisition of Pipeline Medical Technologies Inc., a privately...
The Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May.

The Edwards Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May, becoming the first transcatheter tricuspid repair device to be approved in the world.

Feature | Heart Valve Technology | August 21, 2018 | Jeff Zagoudis
The tricuspid valve has been dubbed “the forgotten valve” by many practitioners in the interventional cardiology spac
Earlier Intervention for Mitral Valve Disease May Lead to Improved Outcomes
News | Heart Valve Technology | July 26, 2018
The number of patients undergoing mitral valve operations are at an all-time high, and new research suggests many...
The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system  is being tested in the SUMMIT Trial.

The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — The pivotal clinical study in the U.S.
A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — A new multi-societal expert consensus document has been released that summarizes the position of thes
Abbott Receives FDA Approval for Third-Generation MitraClip Device
Technology | Heart Valve Technology | July 18, 2018
July 18, 2018 — Abbott announced it received approval from the U.S.
Videos | Heart Valve Technology | July 18, 2018
Jonathon Leipsic, M.D., FSCCT, professor of radiology and cardiology at the University of British Columbia, Vancouver
Overlay Init