Feature | June 10, 2013

Direct Flow Medical Receives IDE Approval for U.S. Trial of Transcatheter Aortic Heart Valve

The company plans to begin the SALUS feasibility trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System

June 10, 2013 — Direct Flow Medical Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System. The device encompasses a transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system that virtually eliminates aortic regurgitation. It is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.

Post-procedural aortic regurgitation following transcatheter aortic heart valve replacement (TAVR) has been shown to be a predictor of long-term mortality. The Direct Flow Medical Transcatheter Aortic Valve System is designed to address this clinical concern by enabling in-situ hemodynamic assessment after the valve is fully deployed in the native valve annulus, as well as limitless repositioning with full distal, proximal and planar control, or retrieval, if required. The system avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic stress for patients.

With receipt of IDE approval, Direct Flow Medical plans to commence its U.S. clinical study evaluating the use of the Direct Flow Medical Transcatheter Aortic Heart Valve System. The system includes a distinctive heart valve with a metal-free frame that will be delivered transfemorally via a flexible, 18 French delivery system. The SALUS Trial is a 30-patient feasibility trial that will be conducted at up to six U.S. clinical sites.

Six-month results from the company’s DISCOVER CE Mark Trial presented at the American College of Cardiology (ACC) 2013 Annual Meeting, which studied the Direct Flow Medical system, demonstrated excellent survivability, sustained hemodynamic improvements and few adverse events, with minimal occurrence of aortic regurgitation.

The Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.

For more information: www.directflowmedical.com

Related Content

TRU-Vu Monitors, 24-inch, surgical, monitors, touch screens, MM-24 Series, MMZBTP-24 Series

Image courtesy of TRU-Vu Monitors

Technology | Flat Panel Displays| September 04, 2015
TRU-Vu Monitors has launched a new line of 24-inch HD surgical LCD monitors and touch screens.
Products | Flat Panel Displays| September 04, 2015
Xarelto, PMSS, XANTUS, ESC 2015, major bleeding, non-valvular atrial fibrillation, NVAF
News | Antiplatelet and Anticoagulation Therapies| September 04, 2015
Janssen Pharmaceuticals Inc. and its development partner Bayer HealthCare announced results from PMSS and XANTUS, real-...
ABSORB STEMI TROFI II trial, ESC 2015, bioresorbable vascular scaffold, BVS, STEMI patients

Image courtesy of Abbott Vascular

Feature | Stents Bioresorbable| September 04, 2015
A drug-eluting coronary stent made of absorbable material performed similarly to gold-standard metal among patients...
CUPID 2, gene transfer therapy, heart failure patients, no benefit, ESC 2015, SERCA2a
News | Stem Cell Therapies| September 04, 2015
Gene transfer therapy to correct an enzyme abnormality involved in myocardial contraction and relaxation did not...
News | Cardiac Resynchronization Therapy Devices (CRT)| September 03, 2015
Sorin Group announced the start of patient enrollment in its TRIUMPH-CRT clinical trial in Europe.
CeRtiTuDe cohort study, cardiac resynchronization therapy, CRT-D, CRT-P, ESC 2015
News | Cardiac Resynchronization Therapy Devices (CRT)| September 03, 2015
Most patients with a cardiac resynchronization therapy (CRT) pacemaker would not benefit from the addition of a...
FFR-CT, HeartFlow, PLATFORM trial, ESC 2015, ICA, fractional flow reserve, computed tomography

Image courtesy of HeartFlow Inc.

Feature | FFR Catheters| September 03, 2015
Results of the PLATFORM trial indicate fractional flow reserve computed tomography (FFR-CT) can obviate the need for...
News | Structural Heart| September 02, 2015
An investigational material known as Bioabsorbable Cardiac Matrix (BCM), designed to prevent cardiac remodeling in...
Overlay Init