Newswise — MINNEAPOLIS, April 3, 2020 /PRNewswire/ -- Mardil Medical, Inc., today announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch™ device. VenTouch is a combination therapy which simultaneously treats the distorted valve, the dilated ventricle and the displaced papillary muscles in patients suffering from Type IIIb Functional Mitral Valve Regurgitation (FMR). VenTouch is a minimally invasive surgical treatment for a condition associated with accelerated heart failure. Over 1,000,000 patients in the United States are afflicted with Type IIIb FMR, one of the most difficult and expensive patient populations in cardiology to manage. This VenTouch therapy improves on earlier generations of the technology with the addition of patient-specific inflatable chambers used to correct the displaced mitral valve papillary muscles associated with FMR.
The patients treated with the improved VenTouch device have responded favorably to the therapy, with marked improvements of mitral valve regurgitation, of quality life and of cardiac structure. In all patients, the FMR was reduced to only mild or trace amounts.
The latest VenTouch therapy was completed on March 23 at Semmelweis University Heart and Vascular Center in Budapest, Hungary. The Hungarian surgical and cardiology teams were supported by a Mardil team led by Drs. Denis Bouchard, George Gellert, and CMO Maurice Sarano.
"After application of the VenTouch device, mitral valve regurgitation was markedly reduced," said Dr. George Gellert, an imaging specialist and prominent trainer of cardiologists on the latest in echocardiography for structural heart procedures. "I was very encouraged by the immediate MR reduction and by the significant benefit in both the ventricular function and correction of the valve anatomy in this difficult-to-treat patient population. In my clinical experience with more than 300 trans-vascular mitral regurgitation interventions, I see some of these patients return with recurring MR following an initially successful therapy. The unmanaged LV dilation causes returning MR in these inoperable patients. Today, these patients have no further therapeutic options. VenTouch can improve leaflet coaptation by correcting the distortion in the valve annulus and LV geometry simultaneously which addresses the root cause of the problem, LV dilation."
Current standards of care treatment for FMR are difficult and high risk open-chest and open-heart surgical valve repair or replacement procedures, or trans-vascular mitral regurgitation interventions. These approaches often leave significant residual FMR and can be ineffective in patients with markedly dilated ventricles. The VenTouch device is a combination therapy designed to address the three primary components of FMR, the distorted mitral annulus, the displaced papillary muscles, and reduction of the ventricular stress and dilation common in this patient population.
"Never before has a mitral valve therapy been so entirely planned in the pre-operative phase. Before the first skin incision we can determine the position of each inflation chamber entirely based on a personalized 3D heart model of the affected patient. This device is about precision and the sound remodeling of each individual patient's dilated heart," said surgeon Dr. Denis Bouchard of the Montreal Heart Institute.
"This work is the culmination of years of research and clinical activity. It is gratifying to see the impact that the VenTouch therapy is having on these patients, and exciting to consider the impact it may have on the broader clinical population," said Aaron Hjelle, COO of Mardil Medical. "Mardil is continuing to develop compelling therapies for patients with cardiac valve disease. Clinical trials for a therapy to treat tricuspid valve regurgitation will begin this year."
Mardil is also initiating clinical trials to study the VenTouch therapy in patients who also have clinically significant Functional Tricuspid valve Regurgitation (FTR) and in patients who have had previous trans-vascular mitral regurgitation interventions that were ineffective, or regurgitation recurred.