Israeli firm develops world’s first heart valve implant without open-heart surgery

Israeli biomedical firm TruLeaf Medical has completed the first phase of a groundbreaking human trial for a catheter-based device that replaces diseased heart valves without open-heart surgery, its parent company Allmed Solutions announced this week. The device, called the RoseDoc docking system, is the first of its kind.

The device was successfully implanted in two patients in India. The trial was the first step in a two-stage catheter-based procedure to replace faulty tricuspid and mitral valves without performing open-heart surgery.

The two patients were suffering from severe, treatment-resistant congestive heart failure caused by leaking tricuspid valves. Neither of them had any viable options left for treatment and were under what is known as a “compassionate care pathway.” According to Allmed Solutions, the procedure was successfully performed in India on Sept. 5.

The RoseDoc system uses a two-stage implantation process: first, a docking station is inserted via catheter; later, a replacement valve is implanted within it. TruLeaf said the second stage, involving the valve implantation, is expected to take place in the coming months under trial protocols.

The procedures marked the first time the RoseDoc platform has been implanted in humans. The Israeli company said the trials provide proof of concept for its technology, designed for the transcatheter replacement of both mitral and tricuspid valves.

The breakthrough is considered highly significant, as millions of patients worldwide suffer from defective heart valves but are not candidates for invasive surgery or existing catheter-based treatments.

Prof. Oz Shapira, CEO of Allmed Solutions Group, said that the trial constituted a “ray of hope” for patients.

“This trial is not only an important step for TruLeaf-Medical, but also a huge step for the entire medical community and a ray of hope for millions of patients,” Shapira said.

He said the Rosedoc platform creates safe solutions to an otherwise high-risk open-heart surgery.

“As a heart surgeon, I deeply understand the absolute necessity of transitioning from a high-risk invasive and complex open-heart surgery to a simple, smart, safe and effective catheter-based solution. TruLeaf Medical RoseDoc platform has the potential to offer an effective treatment to millions of patients with valvular heart disease who have been deemed to be too high risk for surgery and are unsuitable for currently available catheter-based techniques.”

TruLeaf Medical was founded in 2017 by three Israelis – Benjamin Spenser, Nathanael Benichu, and the late Dr. Uri Rosenstein. The team had previously helped develop the Sapien 3 valve, the first transcatheter device for patients with severe aortic stenosis, which was later acquired by Edwards Lifesciences.

The company is now recruiting new patients for additional human trials in India and Uzbekistan, with plans to expand to other countries. It said the success of these trials represents a crucial milestone toward accelerating regulatory approvals and bringing the technology to global markets.