Edwards Hits Record as Aortic Valves Save More Lives in Studyby
Sapien 3 helps reduce death and stroke in heart patients
Results `truly phenomenal,' exceed expectations: Analyst
Edwards Lifesciences Corp. surged to a record after researchers showed its latest heart valve lowered the risk of death and stroke in a broader group of people suffering from severe aortic stenosis, a finding that could swell the market for the products to $5 billion.
Shares climbed 19 percent to $107.19 at 12:31 p.m. in New York, after gaining as much as 20 percent, the biggest intraday increase ever for the Irvine, California-based company. They had risen 28 percent in the past 12 months through Friday as investors waited for results of the study testing the heart valve, called Sapien 3.
Sales of the device, which allows doctors to thread a man-made aortic valve into the heart via an artery rather than cracking open the chest, is currently limited in the U.S. to patients likely to die if they attempted surgery. The company-funded study presented at the American College of Cardiology’s annual meeting showed that patients with an intermediate risk, encompassing about 100,000 Americans, also reap significant benefits by avoiding open-heart surgery.
“Sapien 3 results were truly phenomenal, exceeding even over very bullish expectations,” said Michael Weinstein, an analyst with JPMorgan Chase & Co. in New York who rates the shares overweight. “It’s a different world now.”
After one year in the study:
- 7.4 percent of Sapien patients died vs 18 percent of surgical patients
- 4.6 percent of Sapien patients had a stroke vs 8.2 percent getting surgery
- 1.5 percent of Sapien patients had moderate to severe regurgitation, where the blood leaks backward, versus 0.4 percent of surgical patients
Physicians say they plan to use the transcatheter valve replacement approach, known as TAVR, in about 80 percent of their intermediate-risk patients within a year, said Danielle Antalffy, an analyst at Leerink Partners. She is anticipating a slightly slower adoption as hospitals must gear up for more procedures and questions remain about how long the devices last compared to the sturdy valves that are sewn-in during open-heart surgery.
The findings pave the way for U.S. approval of the devices for intermediate-risk patients, expected before the end of the year, Edwards Chief Executive Officer Michael Mussallem said. The company anticipated its Sapien valves would be approved for the broader group when it boosted the projected market size to $5 billion by 2021 in December. It may happen faster now that there’s proof they are superior and improve survival, a finding that may bring a new group of patients into the market, he said.
“We find that many patients are not treated, and we think part of that is because in the past the primary treatment option for them was open-heart surgery,” Mussallem said. “Having this option would be very good for patients.”
In the U.S., the Centers for Medicare and Medicaid only covers the use of transcatheter valves for patients that have formal U.S. Food and Drug Administration approval, he said. As a result, doctors are very disciplined about which patients are offered the technology. A broader FDA approval would significantly expand Sapien’s use, he said.
Medtronic Plc, which makes a rival device, already has a trial underway in intermediate-risk patients. Those results won’t be available until next year. Meanwhile, Edwards is starting its next study, in patients with a low risk from surgery who currently comprise about half of all patients with severe aortic stenosis, a narrowing of the aortic valve that crimps blood flow to the body.
It will be several years before those results are ready, Mussallem said.