Plus   Neg

Boston Scientific: Clinical Study Data Confirm Benefits Of S-ICD System

Boston Scientific (BSX) reported the final results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator, or S-ICD, System, an approved implantable defibrillator for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction. The trial data demonstrated safety and efficacy of the S-ICD System. In the trial, S-ICD therapy had an inappropriate shock-free rate of 95.9% at 18-months post-procedure, meeting the primary endpoint with a rate comparable to or lower than those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies.

Also, results from the investigator-sponsored PRAETORIAN trial were announced. Investigators confirmed that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing as it offers comparable performance while avoiding lead-related complications and serious infections associated with TV-ICDs.

Separately, Boston Scientific reported positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the WATCHMAN FLX Left Atrial Appendage Closure Device for patients with non-valvular atrial fibrillation. The trial met primary safety and efficacy endpoints with low complication rates, 100% effective closure with next-generation stroke risk reduction technology.

The next-generation WATCHMAN FLX device received CE Mark in 2019. The company plans to further evaluate the WATCHMAN FLX device through continued enrollment in the ongoing OPTION trial as well as in the CHAMPION-AF clinical trial.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Pfizer said Friday it reached a multi-year deal with Gilead Sciences to manufacture and supply Gilead's investigational antiviral remdesivir for COVID-19 patients. Ferring Pharmaceuticals US is recalling various nasal sprays citing superpotency or amounts of desmopressin higher than specified, the U.S. Food and Drug Administration announced in a statement. The recall involves all lots on the market of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL. U.S. President Donald Trump has issued executive orders to ban Chinese mobile application TikTok as well as WeChat, citing a threat to national security and its economy. China's ByteDance Ltd. owns TikTok, a video-sharing mobile app, while Tencent Holdings Ltd. owns WeChat, a messaging, social media, and electronic payment app.
Follow RTT