V-Wave today released results from the 1st-in-human implantation of its investigational interatrial shunt device designed for patients with advanced heart failure, touting a 100% success rate for implantation and no device-related adverse events.
The interatrial shunt is designed to be implanted trans-venously and placed in the atrial septum, where a valve regulates left to right shunting of blood to reduce the chance of paradoxical embolus. The device is also designed to regulate left atrial pressure by shunting excess blood away from the left ventricle.
Results from the test were published in the academic journal Lancet, the Israeli company said.
“We are excited that our 1st scientific paper merited publication in such a leading, high-impact peer review journal. 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,” Dr. William Abraham of The Ohio State University Wexner Medical Center said in a press release.
V-Wave said that the 1st 10 patients, all of whom had Class III systems despite being treated with maximally tolerated HF medications, showed significant improvements in symptoms, exercise capacity and quality-of-life assessments at 3 months post-procedure. Catheter measurements returned lowered left atrial pressure without deterioration of right heart function, the company said.
The company announced 4 principal investigators for the trial, naming Dr. Gregg Stone of Columbia University, Dr. Joann Lindenfeld of Vanderbilt University, Dr. Stefan Anker of Germany’s University Medicine Göttingen and Dr. Josep Rodés-Cabau of Quebec’s Laval University.
“We are fortunate to have a most talented and respected team of principal investigators. With their expert direction, we can develop the scientific basis for interatrial shunting to support applications for regulatory approvals and hasten physician adoption, both in the U.S. and around the world. We believe the V-Wave Shunt has the potential to change the way care is given and fundamentally improve the lives of patients with severe heart failure,” CEO Dr. Neal Eigler said in prepared remarks.
In January, Johnson & Johnson (NYSE:JNJ) joined previous investor Edwards Lifesciences (NYSE:EW) in a $28 million Series B round to support V-Wave. Other groups joining the round included newly-invested TriVentures, Pura Vida Investments and BioStar Ventures, with returning investors Pontifax and the BRM group.
Funds will go to support clinical evaluation and development, addition of senior management and scaling up manufacturing of the HF-treating shunt.