Valtech gets CE mark for transcatheter mitral valve repair device, validating HeartWare's looming $929M takeover
The Cardioband for minimally invasive mitral valve repair--Courtesy of Valtech Cardio

Israel's Valtech Cardio has secured a CE mark for its transcatheter mitral valve repair device, in a win for HeartWare ($HTWR), which is acquiring the company for about $929 million in a bid to enter the burgeoning transcatheter mitral valve repair and replacement space.

Valtech said the European approval was based on a multicenter feasibility trial of more than 50 patients, which found its Cardioband mitral reconstruction system to be safe and effective, first-line option for reducing mitral regurgitation and improving quality of life.

The Cardioband is delivered percutaneously to the heart using a transfemoral (through the leg) approach, avoiding the need for invasive open heart surgery.

The device will compete with fellow transcatheter mitral valve replacements the Mitraclip and the Carillon, from Abbott ($ABT) and Cardiac Dimensions respectively. The Mitraclip has earned FDA approval, making it the only transcatheter device for the mitral valve to boast that distinction.

But the head of FDA's device arm (CDRH), Dr. Jeffrey Shuren, has promised to make review of the class of devices a priority. He seeks to avoid a repeat of the situation with transcatheter aortic valve replacements (TAVRs), in which the agency approved its first TAVR more than 4 years after it earned a CE mark in Europe.

Mitral regurgitation occurs when the leaflets of the mitral valve don't close properly, allowing blood to flow backward from the left ventricle into the left atrium. The release announcing the CE marking says $4.2 million patients in the U.S. have mitral valve disease, making it a multibillion-dollar therapeutic area.

That makes it an attractive opportunity for companies like HeartWare, which are hoping that transcatheter mitral valve devices replicate the financial and clinical success of TAVRs.

Prior to the HeartWare deal, Edwards Lifesciences ($EW), Abbott and Medtronic ($MDT) dropped a combined $1 billion on minimally invasive transcatheter mitral valve replacement makers. Adding to the sense of urgency is the commercial experience with TAVRs, where first movers Edwards and Medtronic dominate, while others like Boston Scientific ($BSX) and St. Jude Medical ($STJ) remain unapproved in the U.S. and are still trying to gain traction elsewhere.

"The Cardioband transfemoral annuloplasty system represents a more reproducible and predictable platform for mitral valve repair than existing solutions. We believe Cardioband will be a natural and clear selection as a first-line treatment for the broadest spectrum of MR patients, since it offers a safer option and, even in early clinical use, has already demonstrated a strong efficacy profile," said HeartWare CEO Doug Godshall earlier this month when announcing the acquisition of Valtech, back when the Cardioband was still unapproved.

Valtech is also developing a transcatheter device for mitral valve replacement (as opposed to repair) and another non-transcatheter device for surgical mitral valve replacement via open heart surgery. Scheduled for launch in 2016 is the CE-marked Cardinal annuloplasty ring system for surgical mitral valve repair via open heart surgery.

Indeed, HeartWare acquired Valtech to transform itself from a specialist in left ventricular assist devices, to a diversified cardiology generalist. The expected CE marking of the Cardioband means the impending deal is off to a good start. And Valtech shareholders will receive an additional 800,000 shares of HeartWare, on top of the 4.4 million shares they were already supposed to receive upon closing.

- read the release