FDA Grants Breakthrough Designation for Heart Failure Device

VisCardia has been granted Breakthrough Device Designation for an implantable technology to treat heart failure (HF). More specifically, the Portland, OR-based company’s VisOne is a device that treats moderate to severe HF with reduced ejection fraction and preserved ventricular synchrony. The system delivers synchronized diaphragmatic stimulation (SDS) therapy. Greg Harris, VP of Clinical and Regulatory Affairs spoke with MD+DI about VisOne and how the device has the potential to make a difference in the lives of HF patients. “Other technologies are usually focused on strengthening the heart which causes the heart to use more oxygen and those kinds of things,” Harris told MD+DI. “Our technology makes it easier for the weak heart to pump.” Harris added, “We implant two bi-polar leads on the underside of the diaphragm using a laparoscope. It’s minimally invasive and it takes two small half-inch incisions that allow us to plant the leads onto the diaphragm. Either subcutaneously, under the skin, or in the abdomen we place a small pulse generator, which detects the cardiac activity. It then sends a small shock to the diaphragm. This just stimulates a small portion of the diaphragm. It doesn’t affect breathing at all.” The company said when stimulating the diaphragm below the heart synchronously with the cardiac cycle, t...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news