WATCHMAN, the Left Atrial Appendage Closure (LAAC) Device from Boston Scientific Corporation (NYSE:BSX) has demonstrated positive safety and efficacy rates. The results were presented at the Heart Rhythm Society’s 38th Annual Scientific Sessions in Chicago, during a late-breaking clinical trial session at Heart Rhythm 2017.
The evaluation of the single-arm, multicenter EWOLUTION registry involved about 1,025 patients and was found to have a high implant success rate, which is effective in stroke reduction. Patients with non-valvular atrial fibrillation (AF) would be the first beneficiaries and more so those with a high threat for stroke and systemic embolism.
Performance of the WATCHMAN device
The results of the WATCHMAN device, which was CE-marked in 2005, illustrate its validity and as an excellent alternative to anticoagulant therapy. Compared to predicted rates of untreated patients, the results of the patients who were using the device had an 84% reduction in the annual stroke rate.
The study enrolled patients at 47 centers throughout Europe. The main investigator and electrophysiologist at St. Antonius Hospital, the Netherlands, Lucas V.A. Boersma stated, “This impressively low ischemic stroke rate favors left atrial appendage closure as an important therapy for patients ineligible for long-term oral anticoagulation.”
Transformation of lives through innovative medical solutions
Boston Scientific has been at the forefront of using innovation in transforming people’s lives. The company, which has been in the market for more than 35 years, has been advancing its already broad range of high-performance solutions with an intention reducing healthcare costs. Being able to reach more patients has also been one its primary agendas.
The company’s senior VP and chief medical officer Kenneth Stein is thrilled about what the calls ‘real-world’ results from the clinical trial program. The surprising thing is that as positive as they are, the registry involved older and sicker patients, something that had been the case in the previous trials.
Meanwhile, there an expectation of the release of additional EWOLUTION data at the annual EuroPCR Scientific Congress in Paris scheduled for May 18. In the meantime, Boston Scientific’s stock closed at $26.23 a fall of $0.14 or 0.53%.