Edwards, Medtronic Heart Valve Systems Are Proven In Low Risk Patients: Studies

(Reuters) – Medtronic Plc and its rival Edwards Lifesciences Corp's non-invasive cardiac valve replacement systems have been found to be as good or better than open-heart surgery in younger, more active patients for whom the drug has been used. Surgical option was considered low risk, according to the results of the trial presented on Saturday.

Both companies have already received approval for their TAVR (Catheter Valve Replacement System) systems for use in patients who are too fragile to undergo surgery and those at intermediate risk. Licensing in low-risk patients would open up a significant new population to devices considered to be vital growth drivers for businesses.

An estimated 165,000 low-risk patients have severe aortic stenosis each year in the United States, Western Europe, and Japan, a condition that can lead to heart failure in as little as two years, Medtronic said.

With TAVR, the replacement heart valve is inserted into an artery via a catheter, which prevents patients from having crack surgery.

"When I do these patients in the morning (later in the day), I find them sitting on a chair, having dinner, asking when they can go home," said Dr. Michael Reardon, who led the # 39, Medtronic study. "As a cardiac surgeon, I can not make any incision small enough to allow my operated patients to do it properly."

Edwards, which owns about 70% of the US TAVR market, estimates that the global market is expected to double to about $ 7 billion by 2024. Both companies have similar market shares outside the United States.

Edwards Sapien 3's TAVR system was superior to surgery for the primary goal of its 1,000-patient trial, which included stroke, death, and rehospitalization one year after the procedure. The TAVR rate was 8.5% versus 15.1% for surgery, showed data revealed at the American College of Cardiology's scientific meeting in New Orleans.

At 30 days, Sapien also had a lower stroke rate – 0.6% versus 2.4% – which was the main safety concern when these systems were introduced for the first time.

Medtronic's Evolut TAVR rival system has achieved the primary goal of its so-called non-inferiority trial on more than 1,000 low-risk patients, proving as safe and effective as a surgical procedure, have shown presented at the same meeting.

The combined rate of fatal or disabling all-cause accidents after two years was 5.3% for Evolut versus 6.7% for surgery, a difference considered statistically insignificant.

At the end of the 30 days, Evolut was much better in terms of security. With TAVR, the composite death rate or disabling stroke was 0.8% versus 2.6% for surgery. The TAVR was also better for other security measures after 30 days.

TAVR systems can cost about five times more expensive than traditional replacement heart valves, which is a major source of revenue for businesses. But they can be globally more profitable because of the much shorter duration of hospital stays and convalescence.

Raj Denhoy, an badyst at Jefferies, expects the size and competition of the VART market to grow as the Boston Scientific Lotus system is about to be approved by the United States this year.

The TAVR "is a pretty spectacular technology that should be used by many more patients than it already is," said Denhoy.