First-Of-Its-Kind Technology Enables Replacement of Diseased Heart Valve without Surgery

Globally, there are tens of millions of patients with severe, life-threatening mitral valve regurgitation (leaky valve) that causes heart failure, heart arrhythmia and brain strokes, resulting in high mortality. Approximately 10% of the global population aged over 75 years suffers from leaky mitral heart valve. Such patients experience a significant reduction in their functional capacity which manifests as fatigue, shortness of breath upon exertion with lower and lower exertion and arrhythmias, thus gradually affecting their daily routine. Patients with leaky mitral valve have a substantially shorter life expectancy than age and gender-matched people. Currently, complex open-heart surgery to repair or replace the leaky heart valve is the most effective treatment for such patients but is offered to just 2% of patients due to a high surgical risk. Now, a unique platform offers a first-of-its-kind technology for allowing implantation of a biological bioprosthesis to replace the diseased valve through catheterization only.

The unique RoseDoc platform developed by TruLeaf Medical (Or Akiva, Israel) enables a ground-breaking procedure that is minimally invasive, performed on a beating heart via two needle punctures without surgery or the use of a heart-lung machine. The procedure is associated with significantly lower risk than traditional open-heart mitral valve surgery. This means that millions of patients across the world, who until now were considered to be inoperable, can receive a new valve and look forward to a substantial improvement in their functional capacity, quality of life and life expectancy.

TruLeaf has received the Helsinki Ethics Committee's approval to conduct clinical trial of its innovative platform in humans. As part of the trial, a prosthetic mitral valve will be implanted via two needle sticks in the groins in a two-stage catheterization procedure without the need for open-heart surgery (transcatheter mitral valve replacement, TMVR). The implantation of the RoseDoc, which replaces the patient's leaky heart valve, will be done in two stages. In the first stage, a docking station will be implanted in the left atrium, followed by implantation of an artificial 'biological' mitral valve prosthesis after a few weeks. The approval to carry out implantation of TruLeaf's TMVR platform in humans comes a few months after completing the R&D of all the components of the platform, as well as a series of successful short-term and long-term animal experiments.

"The main challenge with existing TMVR technologies is achieving optimal anchoring of the valve prosthesis to the heart, given the complex native mitral valve anatomy and physiology,” explained Benjamin Spencer, TruLeaf Medical CEO. “The RoseDoc TMVR platform is technically simple, safe and has been proven to be effective in rigorous long-term animal testing. Complete elimination of the leak prevents progressive dilation of the heart, which, by itself, in a vicious cycle, worsens the leak, leading to a progressive weakening of the heart muscle and intractable heart failure. At present, patients with severe mitral valve leak refractory to maximal medical treatment remain without an effective treatment. The vast majority of these patients are declined surgery due to prohibitive risk. The RoseDoc unique TMVR platform literally gives these patients new hope.”

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