News | May 30, 2014

IDE Approval Granted for U.S. Pivotal Trial of Direct Flow Medical TAVR Device

May 30, 2014 — Direct Flow Medical has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the pivotal phase of the SALUS trial. The SALUS trial is a prospective, non-randomized, multicenter, core lab adjudicated clinical trial, evaluating the Direct Flow Medical transcatheter aortic valve system at up to 30 sites.

The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural aortic regurgitation, a strong predictor of long-term mortality. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with unlimited repositioning of the valve after full deployment. The system avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients.

The primary endpoint of the trial is a composite of all-cause mortality and disabling stroke at 12 months. 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.

An earlier feasibility phase of the SALUS trial conducted in 2013 evaluated the system in 30 patients. The 30-day outcomes were presented by Tuzcu at the 2014 EuroPCR conference, demonstrating a survival rate of 97 percent, low procedural complications, no incidence of stroke, a three percent rate of permanent pacing and 100 percent of patients with mild or less aortic regurgitation. The mean aortic gradient decreased from 44.5 mmHg to 12.7 mmHg at 30 days.

“We have been working closely with the FDA since the early development of the Direct Flow Medical technology, and it has been a collaborative effort, which has led to an approval to start the pivotal phase of the SALUS trial. The technology has shown outstanding performance in clinical trial and commercial settings, significantly reducing the risk of aortic regurgitation and improving patient survival. We look forward to expanding the clinical use to additional centers in the U.S. and continuing to obtain the same strong outcomes in the pivotal trial,” said Charles Davidson, M.D., chief medical officer of Direct Flow Medical.

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 Lifesciences Pascal Tricuspid Valve Transcatheter Repair System Approved in Europe
News | Heart Valve Technology | May 18, 2020
May 18, 2020 — The Edwards Lifesciences Corp.
Key TAVR Takeaways From ACC 2020
Feature | Heart Valve Technology | April 20, 2020 | Dave Fornell, Editor
Some U.S.
Abbott announced its TriClip Transcatheter Tricuspid Valve Repair (TTVR) System has received European CE mark clearance as a non-surgical treatment for people with a tricuspid valve regurgitation (TR). 
Feature | Heart Valve Technology | April 09, 2020
April 9, 2020 — Abbott announced its TriClip Transcatheter Tricuspid Valve Repair (TTVR) System has received European
The Edwards Lifesciences Cardioband for tricuspid valve regurgitation. #COVID19 #coronavirus

The Edwards Lifesciences Cardioband for tricuspid valve regurgitation is one of the device trials being paused for the duration of the COVID-19 outbreak.

News | Heart Valve Technology | March 30, 2020
March 30, 2020 — Edwards Lifesciences Corp.
Conclusions from the TAVR vs surgery trial for aortic valve replacement in the U.K. presented by William D. Toff, M.D. at ACC 20. #ACC20 #ACC2020 #TAVR #TAVR

Conclusions from the real world TAVR vs. surgery trial for aortic valve replacement outcomes in the U.K., presented by William D. Toff, M.D. at ACC 20. 

News | Heart Valve Technology | March 30, 2020
March 30, 2020 — Patients in the United Kingdom (U.K.) who underwent transcatheter aortic valve replacement (TAVR) di
PARTNER 3 trial shows positive results for Sapien 3 in low-risk surgical patients. #ACC20 #ACC2020 #Sapien3 #TAVR
Feature | Heart Valve Technology | March 30, 2020
March 30, 2020 — Low-risk patients undergoing transcatheter aortic valve repair (TAVR) at two years did just as well
News | Heart Valve Technology | March 29, 2020
March 29, 2020 — Worse than expected outcomes were found for survival and quality of life among patients undergoing t
Patients with bicuspid, or two-leaflet, aortic valves who undergo transcatheter aortic valve replacement (TAVR) procedures had a high rate of success and low risk of death or disabling stroke at 30 days, according to new data presented at the American College of Cardiology (ACC) 2020 Scientific Session. #ACC20 #ACC2020
Feature | Heart Valve Technology | March 29, 2020 | Dave Fornell, Editor
March 29, 2020 — Patients with bicuspid, or two-leaflet, aortic valves who undergo transcatheter aortic valve replace
The heart team at St. James University Hospital Dublin was the first to perform a human implant of the CroiValve Duo Tricuspid Coaptation Valve technology for tricuspid repair.  

The heart team at St. James University Hospital Dublin was the first to perform a human implant of the CroiValve Duo Tricuspid Coaptation Valve technology for tricuspid repair.  

News | Heart Valve Technology | March 25, 2020
 
A 3-D reconstruction of a cardiac CT scan showing an implanted Medtronic CoreValve TAVR device. Imagine courtesy of TeraRecon. #TAVR #TAVI

A 3-D reconstruction of a cardiac CT scan showing an implanted Medtronic CoreValve TAVR device. Image courtesy of TeraRecon

Feature | Heart Valve Technology | February 24, 2020 | Dave Fornell, Editor
In August 2019, the U.S.