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:

Related Content

New Target for Treating Heart Failure Identified by Penn Medicine Researchers

Microtubules in heart cells from a healthy patient (left) and from a patient with heart failure. The dense network of detyrosinated microtubules impedes the motion of the failing heart cell during the heart beat. Credit: Ben Prosser lab, Perelman School of Medicine, University of Pennsylvania

News | Heart Failure | June 25, 2018
New research finds changes in cellular struts called microtubules (MT) can affect the stiffness of diseased human heart...
Gencaro Does Not Reduce Atrial Fibrillation Risk in Heart Failure Patients
News | Heart Failure | May 30, 2018
Data from the GENETIC-AF trial was presented in a “Late Breaking Clinical Trials” oral presentation at the European...
Cardiac Contractility Modulation Safe and Effective as Heart Failure Treatment

Image courtesy of Impulse Dynamics

News | Heart Failure | May 18, 2018
In a new study, cardiac contractility modulation (CCM) therapy was confirmed to significantly improve exercise...
V-Wave Closes $70M Financing to Support Pivotal Study of Heart Failure Therapy
News | Heart Failure | May 16, 2018
Israel-based V-Wave Ltd. recently closed a $70 million Series C financing for its proprietary, minimally invasive...
News | Heart Failure | May 14, 2018
Ancora Heart Inc. announced the expansion of the company’s U.S. feasibility study to evaluate the investigational...
Protein Clumping May Contribute to Heart Failure Development

A PET scan detects clumping proteins in rat hearts (top). The enlarged heart (right) is one with heart failure. Other PET scans showing blood flow in the rat hearts (bottom) show that the protein clumps aren't due to circulation problems. Image courtesy of Circulation Research, May 11, 2018.

News | Heart Failure | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
Minnesota Living With Heart Failure Questionnaire Qualified for FDA Medical Device Development Tools Program

The CORolla device from Israel-based CorAssist is one example of new devices being manufactured and tested to treat heart failure. The efficacy of this and other new devices under development can now be assessed with the Minnesota Living With Heart Failure Questionnaire. 

Technology | Heart Failure | May 07, 2018
The U.S. Food and Drug Administration (FDA) has qualified the Minnesota Living with Heart Failure Questionnaire from...
Nation's First Heart Failure and Arrhythmia Center Opening in Ohio

Image courtesy of The Ohio State University

News | Heart Failure | April 04, 2018
The Ohio State University Wexner Medical Center will establish the nation’s first center dedicated to treating those...
Abbott Initiates GUIDE-HF Trial for Improved Outcomes With CardioMEMS Monitor
News | Heart Failure | March 29, 2018
Abbott announced the company has initiated the landmark GUIDE-HF clinical trial using the CardioMEMS HF System. The...
Overlay Init