- Boston Scientific said Tuesday afternoon it received FDA approval for its Watchman FLX device, the latest version of its stroke technology, which the medtech positions as an alternative to blood thinners for individuals with non-valvular atrial fibrillation (NVAF). It plans to begin a limited U.S. launch immediately.
- The left atrial appendage closure (LAAC) device closes off the area of the heart where blood clots commonly form in those patients, Boston Scientific describes. Initial FDA approval came five years ago and the device is reportedly implanted in more than 100,000 patients. The company says the latest version is available in more sizes and can be more easily repositioned or redeployed for precise placement.
- Boston Scientific also affirmed that two clinical studies will continue to assess the device: the OPTION trial comparing it to oral anticoagulants (OACs) in patients who also undergo a cardiac ablation procedure, and the CHAMPION-AF trial, which will look at a broader OAC-eligible population to directly compare the device to novel OACs.
In addition to progressing its transcatheter aortic valve replacement and mitral repair technologies, Boston Scientific believes worldwide expansion of left atrial appendage closure devices will help its largest business — interventional cardiology — achieve a 6% compound annual growth rate between 2019 and 2022.
Early this year, Boston Scientific pegged the global LAAC market as worth $400 million in 2018, on track to hit the $1 billion mark in 2023 and potentially pass the $2 billion mark in 2025. The FLX version of the device has held a CE mark since March 2019 and the company has said it's targeting an expansion to China next year.
Boston Scientific shared 12-month safety and efficacy data on Watchman FLX in May as part of the virtual Heart Rhythm Society conference. A more than 400-patient, company-sponsored trial met safety and efficacy endpoints and demonstrated a 98.8% implant success rate among individuals with NVAF eligible for anti-coagulation therapy but for whom a non-pharmaceutical alternative was also a viable choice.
After FDA approval in 2015 the company began running TV ads in 2017. The device was one of many that came under fire last year during media investigations as the subject of summary adverse event reports hidden from public view by the FDA.
Prior to the latest version's approval, Watchman's momentum has taken some hits from the pandemic. CEO Mike Mahoney said on a late April earnings call the Watchman procedures are "largely deferrable," but that the company believes based on communications with physician operators that postponed procedures will ultimately be recouped.
When asked by Bernstein analyst Lee Hambright in late May about how the pandemic might affect how clinicians consider adopting new products, Mahoney identified Watchman FLX as a device that would not require new training or proctoring.
Boston Scientific said in a statement emailed to MedTech Dive on Wednesday it will initiate a limited market release in the next several weeks following physician training. The company then plans to transition into a full market release in the U.S. later this year.
"We believe this pipeline of patients in need, combined with the anticipation and clinical benefits of the Watchman FLX device, will act as important catalysts for the post COVID-19 recovery curve for the Watchman procedure."
The company is scheduled to report second quarter earnings before market open on July 29.