The Approvals Keep Rolling in for Boston Scientific

Boston Scientific has been on quite a roll lately – when it comes down to nods from FDA. The Marlborough, MA-based company recently announced it received approval for the latest-generation Watchman FLX Pro Left Atrial Appendage Closure (LAAC) Device.

The latest Watchman FLX Pro device is enhanced with a coating designed to reduce device-related thrombus and enable faster, controlled healing and endothelization of the device surface. In addition, newly added visualization markers are intended to enhance device placement for optimal sealing around the LAA.

This device is also available in a new 40mm size option, which will enable physicians to treat a broader range of anatomies with the Watchman technology.

Preclinical research for the new technology has shown positive results for faster, more controlled healing around the device surface. Data across several of these preclinical studies demonstrated that the polymer coating provided an 86% reduction in inflammation three days following the procedure, a 70% reduction of thrombus at 14 days and a 50% increase in endothelial tissue coverage 45 days post procedure.

“There is a rich history of safe use and low thrombosis rates in cardiovascular devices that utilize this thromboresistant polymer coating, and we have adapted that model to provide a more streamlined healing process that begins immediately following LAAC,” said Kenneth Stein, MD, senior vice president and global chief medical officer, Boston Scientific. “We believe this evolution of the Watchman device also gives promise for a future with less thrombosis risk, which may eventually enable a simpler post-implant drug regimen for patients.

The nod comes about three years after the company won approval for the Watchman FLX LAAC device. Boston Scientific inherited the Watchman device when it acquired Atritech in 2011.

The approval also follows Boston Scientific winning a nod for the POLARx Cryoablation System.

The system addresses known limitations by reimagining existing cryoablation offerings, allowing physicians to adjust and expand the new POLARx FIT catheter to fit a patient's individual anatomy during an ablation procedure, which can help mitigate time-consuming and disruptive device changeouts. The device also allows physicians to treat a wider range of pulmonary vein anatomies and create lesions in optimal positions to better deliver therapy to areas of the heart where disruptive signals that cause AF originate.