First Transcatheter Clinical Procedure Performed with Revivent-TC System from BioVentrix

BioVentrix has reported the first-in-man use of its Revivent-TC Myocardial Anchoring System, via a procedure the company calls the Less Invasive Ventricular Enhancement, or LIVE, procedure. The procedure was used to reshape and reduce the left ventricle (LV), of a 61-year-old man suffering from advanced heart failure (HF) in the interventional catheterization laboratory at Vilnius University Hospital in Vilnius, Lithuania. The procedure was performed by Gintaras Kalinauska, M.D., and Gierdrius Davidavicius, M.D.

“Before the LIVE procedure, this patient’s quality of life was severely impacted by his heart failure to the point where he could no longer walk even short distances without discomfort,” said Davidavicius, interventional cardiologist at the Center for Cardiology and Angiology, Vilnius University Hospital and co-investigator. “For patients this fragile, the risks and extended recovery of surgery often preclude any meaningful intervention. The LIVE procedure, which eliminates the most invasive elements associated with conventional surgical reconstruction, greatly expands the patient population that will be able to benefit from this lifesaving procedure.”

The Revivent-TC system uses a myocardial anchor identical to the company’s flagship surgical product, the Revivent Myocardial Anchoring System, which received CE mark in December 2012 and is commercially available and in clinical use at leading heart centers in all major Western and Eastern European markets, according to the company.

The European Journal of Cardio-Thoracic Surgery recently published results highlighting the durability of the Revivent system. In that study, patients sustained a mean reduction in left ventricular end-systolic volume index, the key prognostic indicator for HF, to 43.9 mL/m², well below the 60mL/m² threshold recently defined as providing a survival benefit in heart failure patients. Company officials expect the clinical results are expected to continue with the new transcatheter delivery approach of the Revivent-TC System.

Prior to the Revivent and Revivent-TC Systems, reshaping of the left ventricle 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 into the heart muscle were made to remove the scarred, non-functioning tissue. The invasive nature of SVR limits the use of this procedure due to the fragile nature of many HF patients. In contrast, the LIVE procedure is performed without the need of cardiopulmonary bypass or making incisions into the heart, and now the Revivent-TC system also removes the need to open the patient’s chest.

The Revivent-TC and Revivent Myocardial Anchoring Systems comprise of a series of titanium anchor pairs placed using transmural catheters. The system pulls the lateral LV wall toward the septum to create a fold of tissue that effectively excludes the non-functioning scar created by a previous heart attack. This restores the LV to a more optimal, conical shape and enhances the pumping efficiency of the remaining myocardium. The Revivent-TC System is designed for use in the interventional laboratory whereas the Revivent System is for use in the operating room when the patient’s chest has been opened for a concurrent cardiac procedure.

“There were no complications, and the patient’s heart function improved immediately and has continued to do so,” continued Davidavicius. “Additionally, because of the much less invasive nature of the LIVE procedure, he was discharged just five days post-operatively, which will significantly decrease the cost associated with this treatment. With conventional SVR, the duration of a typical hospital stay can range from six days to more than two weeks.”

Ischemic HF, the most common form of HF, develops after a heart attack creates a scar in the left ventricle. This scar tissue does not contract along with the rest of the ventricle, and prevents it from efficiently pumping blood to the body. As the volume-overloaded left ventricle enlarges and stress on the wall of the heart increases, HF develops and worsens, severely impairing quality of life. According to the European Journal of Heart Failure, it is estimated that the prevalence of HF in Europe stands at 6.5 million people and is rising because of the aging global population.

“We are very pleased with the outcome of this first-in-man LIVE procedure with the Revivent-TC System by the heart failure team in Lithuania,” said Kenneth Miller, president and CEO of San Ramon, Calif.-based BioVentrix. “It is gratifying to accomplish this important step in our mission to develop and deliver heart failure therapy that treats the fundamental cause in the least invasive way possible, so that even very ill patients can benefit.”

BioVentrix is privately held.