On Friday, Boston Scientific announced that FDA has approved the Watchman left atrial appendage closure device, a heart device that while novel was initially rejected.
The device is intended for high-risk atrial fibrillation patients who are seeking an alternative to the warfarin drug, which helps to reduce the risk of stroke.
"Today marks a defining moment in the company's journey towards establishing left atrial appendage closure therapy in the United States. Boston Scientific is proud to offer this potentially life-changing stroke risk treatment option to high-risk patients with AF who have a reason to seek a non-drug alternative to warfarin. This therapy could free them from the challenges of long-term warfarin therapy," said Joe Fitzgerald, executive vice president and president, Rhythm Management, Boston Scientific, in a statement.
Watchman is expected to be launched first in the clinical sites where the device was tested.
After the tortured path to approval - FDA rejected it once, and even after a panel had recommended approval a second time, the agency requested a third panel review last year - analysts were expecting a narrowed label restricting the manner of use.
But that wasn't the case. Here's how Joanne Wuensch, an analyst with BMO Capital Markets Corp., reacted to the approval announcement, in a research note Monday:
After three FDA Panels, the product prevailed; we had been concerned that if/when approved it would arrive with a relatively narrow label – but the label was actually quite broad – “for patients with non-valvular AF who are increased risk for stroke and systemic embolism and are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative.”
Wuensch noted that the demand for Watchman would be relatively high if it is priced appropriately - no information is available on that yet.
Another analyst believes while the label is broad leaving the decision to implant to individual physicians and patients, adoption may be limited by reimbursement decision made by the Centers for Medicare and Medicaid Services.
"Based on the label, Watchman is relevant for any patient who is suitable for warfarin but is either intolerant or unlikely to comply to warfarin therapy," wrote Danielle Antalffy, an analyst with Leerink Partners, in a research note on Monday. "But CMS could narrow the reimbursement scope further -- potentially strictly to patients who are intolerant of warfarin."
While management seeks a new technology add-on payment from CMS, hospitals will be paid according to current codes that pay anywhere between $10,000 and $20,000 wrote Glenn Novarro, an analyst with RBC Capital Markets. While Boston Scientific's management has not revealed the price of the product, Novarro estimates it will be around $15,000.
[Image Courtesy of Boston Scientific]