VisCardia’s implantable VisOne diaphragm stimulator
Novel heart failure device developer VisCardia, Inc. (Portland, Ore.) announced the first implant of the VisONE system for heart failure and the launch of the system’s heart failure pilot study in Ukraine.
The VisONE implantable system delivers asymptomatic diaphragmatic stimulation (ADS) therapy to improve cardiac function. A surgeon laparoscopically implants a medical device equipped with electrodes to deliver electrical pulses to precise areas of the diaphragm. The electrically stimulated diaphragm applies transient intrathoracic pressures gaited to cardiac activity against the cardiac walls, improving both cardiac filling and output, according to the company.
The therapy is non-invasively adjusted and programmed using an external programmer to improve hemodynamic benefit and eliminate undesired stimulatory side effects.
“Our preclinical and early feasibility studies demonstrated ADS improves acute hemodynamic parameters and chronic left ventricular ejection fraction, while remaining asymptomatic and with no adverse effects,” said VisCardia president and CEO Peter Bauer in a company statement. “With our newly developed implantable VisONE system, we intend to demonstrate ADS benefits the majority of moderate heart failure patients with reduced ejection fraction.”
“During this 12-month pilot study, we are optimistic VisONE will deliver comparable benefits as those observed during our ADS feasibility studies,” said Paul Erne, MD, professor emeritus of cardiology at the University Hospital of Basel and former head of cardiology at the Kantonsspital of Lucerne, Switzerland.
The laparoscopic implant took place at the Heart Institute, Kyiv, Ukraine. The patient, a 53-year-old male with a reduced ejection fraction of 17%, remained in symptomatic heart failure despite an optimally titrated medical regimen, and had no alternative treatment options, according to the privately held company.
“The practicality and expediency of this novel and minimally invasive approach reduce critical anesthesia times for this delicate heart failure population, enabling a quicker recovery versus established medical device therapies,” said Oleksandr Plehutsa, M.D., who performed the implant.
Echocardiographic data will be analyzed at the University Hospital of Zurich with statistical analysis performed at the Robertson Centre for Biostatistics in Glasgow, Scotland.
