Medtronic to Pay Up to $458 Million for Device Firm Twelve Inc.

In the third major deal this summer involving makers of transcatheter mitral valves, Medtronic has agreed to pay up to $458 million to acquire an obscure but promising California company called Twelve Inc.

“We have followed the transcatheter mitral valve space closely and firmly believe that Twelve has the most novel technology, along with a strong, proven team,” said Minnesota-run Medtronic’s president of coronary and structural heart division, Sean Salmon, in a statement.

The deal is expected to close in October, and is aimed at speeding up Medtronic’s ongoing progress toward a minimally invasive mitral-valve by at least two years.

Privately funded Twelve has no website, but it filed a report on www.clinicaltrials.gov in April announcing intentions to enroll 10 patients in Poland in an early clinical trial of its heart device. The still-unnamed device allows a physician to install a new mitral valve deep in the heart by wending a skinny tube called a catheter inside it from a small incision elsewhere in the body.

The market for devices that can repair leaky mitral heart valves without requiring open-heart surgery is predicted to quickly grow into a multi-billion-dollar niche. A similar growth trajectory has already been proven with minimally invasive therapies to replace the aortic valve.

Medtronic is one of only two companies that sells minimally invasive aortic valves in the U.S., and it has long been interested in entering the market for mitral valves, which are more difficult for physicians to reach, but potentially more lucrative.

Mitral regurgitation is one of the most common heart diseases in older age, affecting 4 million Americans. The condition affects more than four times the number of people who have aortic stenosis, which is expected to generate as much as $2 billion in sales this year of catheter-delivered aortic valves.

All transcatheter valves are made of special metal that can be folded up inside a narrow tube and then unfurled inside the heart with the use of animated X-rays and manual controls outside the body. The metal frame is like a heart stent with a bioprosthetic valve sewn inside to control blood flow between the left atrium and left ventricle.

In March, analysts with Leerink Partners LLC projected that the U.S. holds about 300,000 patients with functional mitral regurgitation today. Based on a projected average sales price of roughly $30,000 for transcatheter mitral valves, that would translates to a $9 billion initial U.S. market.