Mardil Medical has announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch device for type IIIb functional mitral valve regurgitation. A press release reports that the device is a combination therapy which simultaneously treats the distorted valve, the dilated ventricle and the displaced papillary muscles. It adds that VenTouch is a minimally invasive surgical treatment for a condition associated with accelerated heart failure.
According to the press release, 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 functional mitral regurgitation. Patients treated with the improved VenTouch device have responded favourably to the therapy, with marked improvements of mitral valve regurgitation, of quality life and of cardiac structure. In all patients, the mitral regurgitation was reduced to only mild or trace amounts.
The latest VenTouch therapy was completed on 23 March at Semmelweis University Heart and Vascular Center in Budapest, Hungary. The Hungarian surgical and cardiology teams were supported by a Mardil team led by Denis Bouchard, George Gellert, and Maurice Sarano.
George Gellert, an imaging specialist and prominent trainer of cardiologists on the latest in echocardiography for structural heart procedures, says: “After application of the VenTouch device, mitral valve regurgitation was markedly reduced. I was very encouraged by the immediate mitral regurgitation 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 transvascular mitral regurgitation interventions, I see some of these patients return with recurring mitral regurgitation following an initially successful therapy. The unmanaged left ventricle dilation causes returning mitral regurgitation 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 left ventricle geometry simultaneously which addresses the root cause of the problem, left ventricle dilation.”
Denis Bouchard (Montreal Heart Institute, Montreal, Canada) says: “Never before has a mitral valve therapy been so entirely planned in the preoperative phase. Before the first skin incision we can determine the position of each inflation chamber entirely based on a personalised 3D heart model of the affected patient. This device is about precision and the sound remodelling of each individual patient’s dilated heart.”
Mardil is also initiating clinical trials to study the VenTouch therapy in patients who also have clinically significant functional tricuspid valve regurgitation and in patients who have had previous transvascular mitral regurgitation interventions that were ineffective, or regurgitation recurred.
Aaron Hjelle, COO of Mardil Medical, says: “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. 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.”
