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

News | Heart Failure| October 02, 2015
Cyberonics Inc. announced results from the extension of the ANTHEM-HF clinical study (ENCORE Study). Results of the...
Tryton Side Branch Stent, clinical trial results, Catheterization and Cardiovascular Interventions

Tryton Side Branch Stent image courtesy of Tryton Medical

News | Stents Bifurcation| October 02, 2015
October 2, 2015 — Tryton Medical Inc.
Intact Vascular, TOBA II study, Tack Endovascular System

Image courtesy of Intact Vascular

News | Peripheral Arterial Disease (PAD)| October 01, 2015
Intact Vascular Inc. announced the U.S. Food and Drug Administration has granted conditional approval for a U.S. and...
Johns Hopkins, sticky gel, stem cells, rat hearts, heart attacks

Hydrogel applied to beating rat hearts improves stem cell uptake by the heart muscle and speeds up tissue healing after heart attack. Image courtesy of Johns Hopkins Medicine.

News | Stem Cell Therapies| September 29, 2015
A sticky, protein-rich gel created by Johns Hopkins researchers appears to help stem cells stay on or in rat hearts and...
News | Cath Lab| September 29, 2015
The Innovation Institute announced that Boston Scientific has signed an agreement to become the founding medical device...
Eluvia drug-eluting vascular stent system, 12-month primary patency, Boston Scientific, MAJESTIC trial, CIRSE

Image courtesy of Boston Scientific

News | Stents Peripheral| September 28, 2015
New 12-month clinical trial outcomes assessing the safety and performance of the Boston Scientific Eluvia drug-eluting...
predicting arrhythmias, mcgill university, alternans patterns
News | EP Lab| September 28, 2015
Researchers have discovered how to predict some cardiac arrhythmias several steps before they even occur. It’s a...
News | Antiplatelet and Anticoagulation Therapies| September 25, 2015
The Icahn School of Medicine at Mount Sinai has launched the international TWILIGHT clinical trial to test the safety...
Medisafe, medication management, mHealth platform, blood pressure study, hypertension, adherence
News | Hypertension| September 25, 2015
Medisafe, an mHealth platform for medication management, announced the results of its blood pressure study, which...
Biotronik, NORDIC ICD trial, defibrillation testing, DF testing, shock efficacy
News | Implantable Cardioverter Defibrillators (ICD)| September 24, 2015
Biotronik announced the publication of NORDIC ICD (NO Regular Defibrillation testing In Cardioverter-Defibrillator...
Overlay Init