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

St. Jude Medical, ADO II AS trial, congenital heart disease, PDA, Amplatzer Duct Occluder II AS
News | Congenital Heart| October 19, 2016
St. Jude Medical Inc. announced the launch of the ADO II AS (AMPLATZER Duct Occluder II Additional Sizes) pediatric...
Lantheus, flurpiridaz F-18, myocardial perfusion imaging, MPI, cardiac stress testing, ASNC 2016
News | Radiopharmaceuticals and Tracers| October 17, 2016
Lantheus Holdings Inc. announced in late September that sub-analysis data from the first Phase 3 study of flurpiridaz F...
Medtronic, FIRE AND ICE trial, Arctic Front, cryoballoon catheter ablation, radiofrequency RF ablation, study results, Asia Pacific Heart Rhythm Society Scientific Sessions
News | Ablation Systems| October 17, 2016
Medtronic plc last week unveiled new health economic analysis data from the FIRE AND ICE trial that favor cryoballoon...
transcarotid artery revascularization, TCAR Surveillance Project, Society for Vascular Surgery Patient Safety Organization, SVS PSO,
News | Stents Carotid| October 13, 2016
A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in...
Shockwave lithoplasty system, VIVA 16, Vascular Interventioanl Advances, VIA Physicians, late-breaking endovascular clinical trial results
News | Cath Lab| October 12, 2016
VIVA (Vascular Interventional Advances) Physicians announced a number of highly anticipated late-breaking clinical...
ZipLine Medical, Zip Surgical Skin Closure, cath lab time savings, PACE study
News | EP Lab| October 10, 2016
October 10, 2016 — ZipLine Medical Inc.
Cardioband, first tricuspid valve repair, University Hospital Zurich, Francesco Maisano
News | Heart Valve Technology| October 10, 2016
Francesco Maisano, clinic director at the University Hospital Zurich, recently led a team of cardiac surgeons and...
Mercator MedSystems, Bullfrog Micro-Infusion Device, DANCE trial, VIVA 2016, 13-month results
News | Peripheral Arterial Disease (PAD)| October 07, 2016
Mercator MedSystems recently announced that 13-month data from the DANCE trial was presented during a late-breaking...
Northwestern Medicine, Edwards Lifesciences, Intuity Elite suturless aortic valve, first in Illinois

Edwards Intuity valve image courtesy of Northwestern Medicine

News | Heart Valve Technology| October 07, 2016
October 7, 2016 — A Northwestern Medicine cardiac surgeon was recently the first in Illinois and second in the United
Overlay Init