BioVentrix Expands Transcatheter Heart Failure Treatment to Second European Clinical Site

BioVentrix’s Ventricular Enhancement System seems to be catching on in Europe.

The privately held developer of less invasive heart failure treatments reports that its Revivent-TC Ventricular Enhancement System, via Less Invasive Ventricular Enhancement (LIVE procedure) was used at a second clinical site in Europe. Doctors performed the left ventricle (LV) reducing/reshaping procedure on a 64-year-old man suffering from ischemic heart failure. Prof. Petr Neuzil and Ivo Skalsky, M.D., performed the surgery at Na Holmoce Hospital in Prague, Czech Republic, without opening the man’s chest or using a heart-lung bypass machine.

“The Revivent-TC hybrid system allows treatment of both worsening heart failure patients and those who are already very ill without opening the chest,” said Neuzil, head of cardiology and director of the cardiac arrhythmia service at Na Holmoce Hospital. “This is a major breakthrough for this patient population that will lower the barrier to intervention for all heart failure classifications.”

Within three days of the LIVE procedure, the patient’s ejection fraction, or volume of blood pumped out of the LV with each heartbeat, improved by 45 percent, rising from a preoperative measurement of just 31 percent.

The Revivent-TC System uses a myocardial anchor identical to the company’s flagship surgical product, the Revivent Myocardial Anchoring System, which is commercially available in Europe. Prior to the Revivent technology, reshaping of the LV involved an invasive procedure known as surgical ventricular restoration (SVR), which required cutting through the patient’s sternum to expose the heart, then stopping and supporting it with cardiopulmonary (heart-lung) bypass while incisions were made into the LV to remove the scarred, non-functioning tissue. The invasiveness of SVR limits its use due to the fragile nature of many heart failure patients.

“Placement of the Revivent-TC Ventricular Enhancement System using a transcatheter approach fully leverages the concept of treating heart failure in a less invasive manner,” said Lon Annest, M.D., chief medical officer of BioVentrix. “For the first time, the quality of life for patients with very few treatment alternatives can be improved without exposing the patient to undue surgical risk. The LIVE procedure not only reduces excessive volume and wall stress, it also reshapes the left ventricle to improve its pumping efficiency, which is key to treating the underlying cause of heart failure.”

Based in San Ramon, Calif., BioVentrix develops and commercializes minimally invasive and non-surgical heart failure treatments.