March 28, 2016 — V-Wave Ltd, maker of an investigational interatrial shunt device for patients with advanced heart failure (HF), announced the results of its first human implants were published in The Lancet. The study, performed at the Quebec Heart and Lung Institute, Laval University, Quebec, Canada, was led by structural heart disease expert Josep Rodés-Cabau, M.D.
The first 10 consecutive patients had Class III symptoms despite being treated with maximally tolerated HF medications and had poor left ventricular function. All were successfully implanted with the shunt during a minimally invasive procedure that took generally less than one hour, and were discharged home the next morning.
There were no device-related adverse effects. After three months, patients had significant improvements in symptoms, exercise capacity and quality-of-life assessments. Catheter measurements showed lowering of left atrial pressure without deterioration of right heart function. These findings are consistent with the shunt diverting just the right amount of blood from the left-side to the right-side of the heart.
“We are excited that our first scientific paper merited publication in such a leading, high-impact peer review journal,” said William Abraham, M.D., steering committee chairman and director of cardiovascular medicine at The Ohio State University Wexner Medical Center. “Studies in larger populations with longer-term follow-up are ongoing and a pivotal, randomized, controlled trial targeting patients in North America, the EU and Israel is being planned. From these data, we hope to understand the safety, efficacy and patient populations most likely to benefit from interatrial shunting. There is good reason to expect the V-Wave Shunt will be helpful not only in patients with reduced left ventricular function but also in the nearly one-half of HF patients where it is preserved.”
HF is the end-stage of most forms of heart disease, affecting six million Americans. Despite advances in therapy, premature death, recurrent hospitalization and deteriorating quality-of-life remain a growing problem and represent a large burden to healthcare systems.
V-Wave also announced the names of four co-principal investigators who will guide the company’s future clinical trials program:
- Gregg Stone, M.D., professor of medicine at Columbia University, is an interventional cardiologist and structural heart disease specialist;
- Joann Lindenfeld, M.D., professor of medicine at Vanderbilt University and current president of the Heart Failure Society of America;
- Stefan D Anker, M.D., professor for innovative clinical trials, University Medicine Göttingen, Germany, is councillor of the Board of the European Society of Cardiology; and
- Josep Rodés-Cabau, M.D., associate professor of medicine at Laval University, Quebec, who has the most experience implanting the V-Wave Shunt.
All are experienced and widely published academicians, noted clinical trialists and recognized authorities in their specialties.
For more information: www.vwavemedical.com