News | August 29, 2014

Direct Flow Medical Gains CE Mark for 23 mm Valve and Implantation Without Use of Contrast

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 that can be treated with this technology. The company also announced receipt of the CE mark for implantation of all its valves without the use of contrast media, protecting patients from kidney injury during transcatheter aortic valve implantation (TAVI).

The company now has a valve portfolio that includes 23 mm, 25 mm, 27 mm and 29 mm valves, which can treat patients with annulus sizes from 19 mm to 28 mm. All Direct Flow Medical valves feature a unique, double-ring design that conforms to the anatomy and creates a tight and durable seal around the annulus. The valves allow for complete assessment of hemodynamic performance and unlimited repositioning until optimal results are obtained. All valves can be delivered through the same, low profile and flexible delivery system.

“These approvals are a testament to our continuous focus on innovation and patient outcomes. Physicians will not only be able to treat a broader patient population, but will also be able to implant this technology with no contrast and no compromises,” said Bernard Lyons, CEO of Direct Flow Medical. “Our pipeline of structural heart technologies is strong, and we continue to invest in new products and new indications for our unique therapeutic platform.”

The Direct Flow Medical valve is designed to improve TAVI outcomes by virtually eliminating aortic regurgitation, offering unlimited repositionability during the procedure and reducing overall complications. Acute kidney injury occurs in about 22 percent of patients undergoing TAVI, increasing their risk of peri-procedural complications, prolonged hospitalization and mortality.

“Use of contrast during angiographic procedures is a well-documented cause of acute kidney injury,” said Charles Davidson, M.D., chief medical officer of Direct Flow Medical. “By eliminating or reducing the quantity of contrast administered during TAVI, we will be able to better protect the kidneys and minimize peri-procedural complications.”

The Direct Flow Medical transcatheter aortic valve system is commercially available in Europe. In the United States, the company is progressing towards regulatory approval and is currently enrolling patients in its SALUS pivotal trial.

For more information: www.directflowmedical.com

Related Content

Edwards LifeSciences Recalls Sapien 3 Certitude Delivery System
News | Heart Valve Technology| January 11, 2018
The U.S. Food and Drug Administration (FDA) announced that Edwards LifeSciences is recalling its Certitude Delivery...
Videos | Heart Valve Technology| January 04, 2018
Adam Greenbaum, M.D., co-director, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, explains how hi
Edwards Acquires Harpoon Medical
News | Heart Valve Technology| December 07, 2017
December 7, 2017 — Edwards Lifesciences Corp.
Videos | Heart Valve Technology| November 15, 2017
Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, is the principal investigato
New Analyses Reinforce Hemodynamic Benefits of Evolut TAVR Platform in Intermediate-Risk Aortic Stenosis Patients
News | Heart Valve Technology| November 08, 2017
Medtronic plc recently presented new clinical research to support the positive clinical performance of the Evolut...
Videos | Heart Valve Technology| November 08, 2017
Stephen Worthley, MB, BS, Ph.D., director of cardiac catheterization, University of Adelaide, Australia, presents the
Videos | Heart Valve Technology| November 08, 2017
Philippe Genereux, M.D., co-director of the structural heart program at the Gagnon Cardiovascular Institute at Morris
Harpoon Mitral Valve Repair System data reported at TCT 2017
Feature | Heart Valve Technology| November 07, 2017
November 7, 2017 – A new study has found that a pioneering device to repair heart valves is safe and effective, and c
Videos | Heart Valve Technology| November 07, 2017
Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, explains the current state o
Overlay Init