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

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