Feature | September 11, 2013

Third TAVI Vendor Enters U.S. Clinical Trials

First patient enrolls in SALUS Trial of Direct Flow Medical transcatheter aortic valve

September 11, 2013 — Direct Flow Medical Inc. announced the first patient enrollment in the U.S. SALUS clinical trial. The trial will study the Direct Flow Medical Transcatheter Aortic Heart Valve System, which encompasses a distinctive transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system designed to eliminate aortic regurgitation. The device is intended to improve the long-term survivability of aortic stenosis patients by resolving the clinical issues associated with current commercial valves.

The SALUS Trial is a non-randomized, multi-center, core lab-adjudicated, investigational device exemption (IDE) trial of 30 patients being conducted at six U.S. clinical sites. Principal investigators for the SALUS Trial are Murat Tuzcu, M.D., vice chairman of the department of cardiology, Cleveland Clinic, and Patrick McCarthy, M.D., director of the Bluhm Cardiovascular Institute and chief of cardiac surgery, Northwestern Memorial Hospital.

William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital performed the first Direct Flow Medical case in the United States.

"The team at Henry Ford Hospital is pleased to be the first in the U.S. to implant the Direct Flow Medical heart valve," said O'Neill. "A device that is repositionable and able to pass through smaller diameter blood vessels is an important advance in the next generation of transcatheter aortic valve replacement (TAVR) systems. This could help patients who have not been good candidates for earlier TAVR devices."

The Direct Flow Medical Transcatheter Aortic Valve System is designed to achieve optimal outcomes by enabling in-situ hemodynamic assessment after the valve is fully deployed in the native valve annulus, as well as repositioning with full distal, proximal and planar control, or retrieval, if required. The system avoids rapid pacing of the heart during deployment, and does not require post-dilatation following placement, minimizing the risk of hemodynamic stress for patients.

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

Edwards, Sapien 3 transcatheter heart valve, Canada, approval
News | Heart Valve Technology| July 27, 2016
Edwards Lifesciences Corp. announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for...
PCI outcomes, public reporting, high-risk patients, JAMA Cardiology, Beth Israel Deaconess Medical Center study
News | Cath Lab| July 27, 2016
July 27, 2016 — A number of states mandate public reporting of mortality outcomes following certain cardiac procedure
Abbott, Absorb bioresorbable stent, dissolving, UAB, University of Alabama at Birmingham, first in state
News | Stents Bioresorbable| July 26, 2016
On July 20, Massoud Leesar, M.D., of University of Alabama at Birmingham Hospital implanted a patient with Absorb, the...
CMS, Overall Hospital Quality Star Rating, national distribution, quailty of care
News | Business| July 26, 2016
July 25, 2016 — The Centers for Medicare and Medicaid Services (CMS) announced that it expects to launch its new Over
Stryker Sustainability Solutions, Angiodynamics Soft Vu Omni Flush Angiographic Catheters, recall
News | Angiographic Catheter| July 25, 2016
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush...
Million Hearts Cardiovascular Disease Risk Reduction Model, CMS, reduce heart attacks and strokes, participants
News | Patient Engagement| July 22, 2016
July 22, 2016 — The Centers for Medicare & Medicaid Services (CMS) recently announced 516 awardees in 47 states,
heart failure, after first heart attack, cancer risk, JACC study
News | Cardiac Diagnostics| July 21, 2016
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared...
Absorb, bioresorbable stent, BVS

The Abbott Absorb stent gained FDA clearance in July 2016. It has metallic markers at each end so it can be visualized for proper positioning under angiographic X-ray imaging. 

Feature | Stents Bioresorbable| July 21, 2016 | Alphonse Ambrosia, D.O.
Some have labeled bioresorbable scaffolds (BRS), also known as bioresorbable stents, as the fourth evolution of inter
mitral valve surgery outcomes, twisting of the heart, echocardiography, NICSMR, JACC Basic to Translational Science
News | Heart Valve Technology| July 20, 2016
A novel study has found a simple pre-operative echocardiographic measurement of the amount of torsion of the heart...
TITAN II Trial, Carillon Mitral Contour System, Cardiac Dimensions, Open Heart journal, functional mitral regurgitation, FMR
News | Annuloplasty Rings| July 20, 2016
New data from the TITAN II trial confirm the safety and efficacy of the Carillon Mitral Contour System in the treatment...
Overlay Init