MedTech Startup Gets Okay For Trial Of Prosthetic Heart Valve

Israeli medtech startup TruLeaf has received approval from the Helsinki Ethics Committee in Uzbekistan to conduct clinical trials of its prosthetic heart valve in human subjects. 

The TruLeaf trial involves a device to treat a leaky mitral valve. This valve opens between two of the four chambers of the heart, regulating the flow of blood from the left atrium into the left ventricle below. 

The Helsinki Ethics Committees safeguard ethics in medical research involving humans and are found in multiple nations around the world. 

The trial will implant a prosthetic mitral valve via the groin in a two-stage catheterization procedure, known as transcatheter mitral valve replacement (TMVR), without the need for open-heart surgery. 

According to TruLeaf, its RoseDoc platform is the first ever to allow the valve to be replaced via catheterization and without surgery or a cardiopulmonary (heart-lung) bypass machine. 

The startup says its minimally invasive procedure also involves substantially lower risk compared to traditional open-heart mitral valve surgery and can be an option for patients deemed too high risk for surgical treatment. 

“The main challenge with existing transcatheter TMVR technologies is achieving optimal anchoring of the valve prosthesis to the heart, given the complex anatomy and physiology of the native mitral valve,” said TruLeaf Medical CEO Benjamin Spenser. 

“Completely eliminating the leak prevents the progressive dilation of the heart, which otherwise worsens the leak in a vicious cycle, leading to further weakening of the heart muscle and intractable heart failure,” he said. 

“Currently, patients with severe mitral valve leaks that are unresponsive to maximal medical treatment have no effective options. The vast majority of these patients are declined surgery due to prohibitive risk. The unique RoseDoc TMVR platform provides a potential lifeline for these patients.”