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

March 29, 2012 by MassDevice staff

Boston Scientific's Alair asthma system gets the OK from CTAF; FDA warns Lucero Medical on Enduramesh manufacturing and IntelliCell Biosciences on marketing of aesthetic stem cell treatment; FDA releases final guidance on benefit-risk determinations; and more.

MassDevice.com 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.

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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.

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