Boston Scientific’s Alair asthma treatment gets a thumbs-up | Regulatory Roundup

 BSX’s Alair asthma system gets the OK from CTAF
Boston Scientific‘s (NYSE:BSX) Alair bronchial thermoplasty system met all 5 safety and effectiveness endpoints in a review by the California Technology Assessment Forum.

CTAF members concluded that the device has FDA approval, has scientific support of its claims to improve health outcomes for chronic asthma patients, does in fact improve health outcomes, is as beneficial as any alternative treatment option and provides an improvement that’s unattainable outside of investigational settings.

The Alair system delivers precise thermal energy to lung tissue via bronchoscope to reduce excessively smooth muscle, decreasing the airways’ ability to constrict.

The Natick, Mass.-based met-tech titan recently won a nod from the Centers for Medicare & Medicaid Services, which approved reimbursement for the Alair device via a separate "pass-through" payment when the procedure is performed in outpatient settings.

The report represents the 1st published technology assessment in support of the Alair system, according to Boston Scientific. Read more

 FDA warns Lucero Medical on Enduramesh manufacturing
The FDA warned Lucero Medical on manufacturing violations of its Enduramesh implantable spinal vertebral replacement devices, which the federal watchdog agency said were not subject to proper design control procedures, complaint handling practices and other necessary measures.  Read more

 FDA warns IntelliCell Biosciences on marketing of aesthetic stem cell treatment
The FDA warned IntelliCell Biosciences that it needs to obtain proper licenses for its IntelliCell stem cell treatment, which it markets as an aesthetic therapy which "can be used "off-label to treat various patient ailments." Read more

 FDA releases final guidance on benefit-risk determinations
The FDA’s Center for Devices & Radiological Health released a finalized guidance on the how the federal watchdog agency will balance benefits and risks when reviewing pre-market approval and de novo applications for medical devices. Read more

More medical device regulatory news from MassDevice.com

 Zoll wins 510(k) for X series monitor defibrillator

 SoundCure touts FDA clearance and CE Mark for Seranade tinnitus treatment system

 Given Imaging lands expanded Japanese indication for PillCam

 Athersys wins German OK for solid organ transplant trial

 Smiths Medical withdraws CoZmonitor blood glucose system as test strips are discontinued

 Merit Medical lands 510(k) for QuadraSphere Microspheres

 VentriPoint wins CE Mark for pulmonary arterial hypertension application

 Cardica applies CE Mark to its MicroCutter Xchange surgical cutting and stapling system

 Benvenue Medical enrolls 250th patient in Kast trial for Kiva vertebral augmentation system

 SpinalMotion touts CE Mark for 2 Kineflex cervical disc implants

 Imalux lands CE Mark for Niris OCT system

Building Better Companies at DeviceTalks Minnesota DeviceTalks Minnesota's leadership track is designed to provide attendees with insights on topics such as: Navigating the path to market Reimbursement Winning regulatory approval Corporate culture Entering global markets Leadership Join industry leaders and medical device professionals at the most awaited medtech conference of the year, DeviceTalks Minnesota. Use code SAVE15 to save 15%! REGISTER NOW