News | Heart Failure | July 06, 2015

DC Devices Completes Enrollment In Clinical Trial of InterAtrial Shunt Device for Heart Failure

Company also announces name change to Corvia Medical

Corvia Medical, IASD, REDUCE LAP-HF, InterAtrial Shunt Device, heart failure

July 6, 2015 - DC Devices Inc. announced that it has completed enrollment and implants in the REDUCE LAP-HF trial, an open label, multi-center, single-arm study of the InterAtrial Shunt Device (IASD). The IASD is a transcatheter device for the treatment of diastolic heart failure (DHF), which is also known as heart failure with preserved ejection fraction (HFpEF).

The company also announced that it has changed its name to Corvia Medical, Inc.

The REDUCE LAP-HF trial is designed to evaluate the safety and performance of the IASD System in the treatment of heart failure for patients with preserved or mildly reduced ejection fraction who have elevated left atrial pressure and remain symptomatic despite appropriate medical management. Sixty-four patients were implanted at 18 centers in 11 countries. The primary safety endpoint is device-related major adverse cardiac cerebrovascular events (MACCE) and systemic embolic events through six months post-implant.

Principal investigator Prof. Chris Hayward, senior staff cardiologist, Heart Failure and Transplant Unit at St. Vincent's Hospital in Sydney, Australia, commented, "We have treated 10 patients with the IASD System and are very pleased with the results. Many of our patients have been able to return to activities they had previously abandoned, with improvement in their exercise capacity and heart failure symptoms."

Co-investigator David Muller, M.D., director of the cardiac catheterization laboratory, St. Vincent's Hospital, Sydney, commented "The system is elegant and I found it extremely easy to use." He continued, "We have seen substantial benefit in individuals who were previously very symptomatic. I look forward to offering this treatment to more of my patients."

The IASD System is designed to reduce pressure in the heart by allowing blood to flow between the left and right atria. During the minimally-invasive catheter-based procedure, an interventional cardiologist places the IASD through a small opening in the atrial septum. After the implant is deployed, a small passage is formed between the left and right atria so blood can flow between the two chambers, potentially lowering pressure in the left atrium, which is intended to reduce the symptoms of heart failure.

For more information: www.corviamedical.com

Related Content

EMPRISE Study Shows Empagliflozin Reduces Heart Failure Hospitalization with new data presented at AHA 2018. #AHA18 #AHA2018
News | Heart Failure | November 07, 2018
November 6, 2018 – Initial results from the real-world EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) s
Acute Heart Failure Mortality, Rehospitalizations Reduced With Blood Volume Measurement
News | Heart Failure | November 02, 2018
In a new study, acute heart failure patients who received individualized treatment by blood volume measurement with the...
Daxor Corp. Collaborating With CHF Solutions on Heart Failure Fluid Overload Management

CHF Solutions' Aquadex FlexFlow System

News | Heart Failure | November 01, 2018
November 1, 2018 — Daxor Corp.
NHLBI Pauses CONCERT-HF Heart Failure Trial
News | Heart Failure | October 29, 2018
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, is pausing the...
A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC 2018. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at ACC earlier this year.

A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC 2018. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at ACC earlier this year.

Feature | Heart Failure | October 19, 2018
October 19, 2018 — Abbott announced today that the HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S
Ohio State First in U.S. to Test Shunt Device for Heart Failure
News | Heart Failure | October 04, 2018
The Ohio State University Wexner Medical Center is first in the country to test a new medical device designed to help...
Mitral Regurgitation Volume Reduced at One Year in REDUCE FMR Trial
News | Heart Failure | September 28, 2018
Heart failure patients who received the Carillon Mitral Contour System in the REDUCE FMR clinical trial showed a...
Overlay Init