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| Harpoon system--Courtesy of Harpoon Medical |
Harpoon Medical reported at the TCT conference in San Francisco that all 10 patients in a feasibility study of its investigational minimally invasive mitral valve repair technology experienced a reduction or elimination of mitral valve regurgitation (MR).
MR occurs when blood flows backward with every contraction of the heart through ruptures in degenerated mitral valves and into the left atrium. The Harpoon system installs sutures, known as ePTFE neochords to plug the rupture in the valve. But it accomplishes the task using a minimally invasive technique conducted on a beating heart, sparing the patient risky open-heart surgery, which involves use of a heart-lung machine while the heart is temporarily prevented from beating.
Harpoon said the device achieved a 100% procedural success rate, and all patients experienced a reduction in MR to mild or less. Both patients with 6-month echocardiographic follow up had no MR following the valve repair procedure. In addition, the average procedure time was 1 hour and 47 minutes, according to the presentation slides, compared to three to 6 hours for conventional mitral valve repair surgery.
"We were delighted to share the mounting clinical evidence that the Harpoon technology enables true minimally invasive mitral valve repair on the beating heart, avoiding cardiopulmonary bypass, cardiac arrest, and conventional open heart surgery," said Harpoon founder Dr. James Gammie of the University of Maryland School of Medicine, in a statement. "The Harpoon system successfully implanted ePTFE neochords on the diseased mitral valve leaflets and restored normal mitral valve function. This beating-heart, image-guided minimally invasive approach has great potential to alter the therapeutic landscape for mitral regurgitation."
The Harpoon system exhibited a strong safety profile, with no adverse event like stroke, heart attack or renal failure occurring. Two of the patients needed a reoperation in the days following the procedure, and one needed a reoperation for recurrent MR after one of the neochords became untied, according to the presentation slides.
All patients received three to 5 neochords (one per rupture). They are implanted via a small incision on the left side of the chest (referred to as a transapical approach). The Harpoon device inserts an introducer valve into the left ventricle. Then the tip of the Harpoon device is extended and positioned beneath the rupture in the valve with the guidance of cardiac imaging. Next, a needle quickly (within seconds) installs the suture, which plugs the rupture by covering it with a knot. The procedure can be repeated for the implantation of additional sutures.
After the sutures are implanted and the introducer valve is removed from the heart, the sutures are tightened under the guidance of cardiac imaging. This occurs by lengthening a chord that extends downward from the implanted suture into the left ventricle. Finally, the chords used for tightening are secured to the outside surface of the heart using small square of Teflon felt, according to a company video.
Harpoon says it employs a traditional surgical technique in a minimally invasive manner. While the Harpoon system is not a transcatheter device, it does avoid many of the risks of open heart surgery, and shifts the risk/benefit profile in favor of earlier stage MR patients, who may otherwise adopt a wait-and-see approach to the condition.
Over the last few months, Abbott ($ABT), Medtronic ($MDT) and Edwards ($EW) have spent $1 billion-plus acquiring early-stage transcatheter mitral valve replacement companies, and Boston Scientific announced a $200 million option to acquire another such company, but the repair market is showing promise as well. It will be interesting to see whether replacement or repair dominates the space, or if there is room for both treatment paradigms.
Harpoon says 60% of the mitral valve surgeries in the U.S. are for repair.
The only approved transcatheter devices for the mitral valve are in the repair arena, led by Abbott's FDA-approved Mitraclip, which earns $250 million per year. Cardiac Dimension's Carillon device and Valtech's Cardioband have CE marks.
Germany's coramaze technologies recently announced a $5.05 million Series A round for its transcatheter mitral valve repair device, which uses the preferred transfemoral (through the leg) approach, as opposed to Harpoon's transapical (through the chest approach). Coramaze's investigational device is aimed at functional mitral valve regurgitation, while Harpoon's is for patients with degenerative mitral valve regurgitation.
Last Harpoon raised $3.2 million in a Series A funding round led by Epidarex Capital.
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