Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device

Boston Scientific (NYSE:BSX) shares took a hit yesterday after a Centers for Medicare & Medicaid Services proposal that would limit coverage for the Watchman anti-stroke device. Investors also likely reacted to a pair of Class II recalls from the FDA, sending BSX shares down -4.2% to $18.01 apiece yesterday. Watchman, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke, was approved by the FDA in March and asked for a CMS coverage decision in May. The federal health insurer proposed to limit coverage for Watchman to patients in approved clinical trials who can’t take warfarin, an anti-coagulant drug. Earlier this week, Boston Scientific touted data from a real-world registry showing a 2.8% rate of serious adverse events at 7 days. The company reported that 92.7% of patients were free from serious adverse events at 1 month post procedure. A total of 61.8% of patients were deemed contraindicated for oral anticoagulants in the study, which is slated to follow patients for 2 years. “At this time, there is insufficient evidence to determine that percutaneous LAA closure using an implanted device improves health outcomes compared to non-invasive standard medical therapies for Medicare beneficiaries with [non-valvular atrial fibrillation]. Therefore, LAA closure using an implanted device should only be considered in patients with NVAF with a high stroke risk and a contraindicati...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Stroke Source Type: news