Boston Scientific Corp.’s Watchman improved survival in patients with erratic heart rates after four years, an unexpected finding that may help create a $500 million market, said Chief Executive Officer Michael Mahoney.
The device is inserted into the heart to close a cul-de-sac where blood pools in patients with atrial fibrillation, the most common erratic heart rate. Patients given Watchman were 40 percent less likely to have a stroke, form a clot or die than those getting the blood thinner warfarin in a study presented yesterday at the Heart Rhythm Society meeting in Denver.
The findings should lay to rest questions about the device, which was shown to carry risks when it was implanted by physicians without much experience, said Vivek Reddy, the lead researcher and director of the cardiac arrhythmia services at Mount Sinai School of Medicine in New York. Even with complications from the insertion, patients treated with Watchman have a lower risk of stroke and death from any cause, he said.
“It’s comforting to know that with longer follow up, the device’s effectiveness doesn’t drop off, it increases,” Reddy said in a telephone interview. “The 34 percent decrease in mortality is extraordinary.”
The findings should bolster demand for the product in Europe and help the second-biggest U.S. maker of heart devices win Food and Drug Administration approval, Mahoney said in a telephone interview. Boston Scientific, based in Natick, Massachusetts, plans to file for approval by the end of the month and hopes for a decision by the first quarter of next year, he said.
“This is an important part of our growth strategy,” Mahoney said. “Watchman is one of the most clinically tested devices ever prior to FDA approval. We feel like with the body of evidence we have, this deserves to be approved.”
Boston Scientific rose 1.8 percent to $8.45 at the close in New York. The shares have gained 35 percent in the past 12 months.
Boston Scientific is counting on five new products obtained through acquisitions that have just reached the U.S. market or are in late development to help return the company to growth in the second half of 2013, Mahoney said. The company is grappling with decreasing demand and falling prices for cardiac devices that account for almost half its annual revenue, as sales have declined for three consecutive years.
Two studies presented at the meeting on the company’s new S-ICD, a defibrillator that doesn’t require leads to be attached to the heart, may bolster its use, investigators said.
The work from researchers at the Academic Medical Center in Amsterdam found the novel devices are being used mainly in younger males. A review of 369 patients found about 7 percent had inappropriate shocks after 15 months, less than half the rate found in small, early studies. A second review showed the one-year mortality rate was 2.7 percent in patients getting the device to replace an infected defibrillator compared with the 8.4 percent expected death rate with older devices.
The improved results stem from better patient selection, improved programming of the devices and greater experience of the doctors implanting them, said Louise Olde Nordkamp, a doctor and researcher at the Academic Medical Center in Amsterdam.
More than 2.7 million Americans and 15 million worldwide suffer from atrial fibrillation. With the condition, the heart quivers instead of beating efficiently, allowing blood to pool and potentially form clots that cause strokes. While blood thinning medicines like warfarin are used to stop the blood from sticking together, the Watchman also can prevent clots.
The longer-term results should help the company win U.S. approval for the novel technology and boost the use of the device once it hits the market, said Danielle Antalffy, an analyst with Leerink Swann in New York, in a note to investors.
Recent approvals of new blood thinners, including Xarelto from Johnson & Johnson and Bayer AG and Eliquis from Pfizer Inc. and Bristol-Myers Squibb Co., are siphoning sales from warfarin, a form of rat poison used for decades to thin the blood. Xarelto is getting almost as many new prescriptions from cardiologists as warfarin, with about 37 percent of the market, according to IMS Health, which tracks industry data.
Warfarin is considered inferior to the newer medicines, which aren’t affected by diet and don’t require routine blood tests, said Jason McGorman, an analyst with Bloomberg Industries in Princeton, New Jersey. Watchman was tested against warfarin so it’s not clear how doctors will compare it to the newer drugs, he said in a telephone interview.
“There are very few things in medicine that get you a benefit of this magnitude,” said Ken Stein, Boston Scientific’s chief medical officer for cardiac rhythm management. “We’re hopeful that with the strength of this data we get pretty quickly through the FDA process.”
While the company plans additional studies to confirm how the device fares once it’s approved, “the heavy lifting is done,” Stein said.