Long-term data for Abbott’s Absorb “highlight the need for continued improvements” in BRS tech

Hours before Abbott (NYSE:ABT) presented three-year data from a pivotal trial of its Absorb bioresorbable scaffold, the FDA updated a letter to healthcare providers, writing that the device continues to show an increased rate of major adverse cardiac events and thrombosis compared to patients treated with a drug-eluting stent.

“The FDA’s recommendations for health care providers outlined in our previous letter remain unchanged,” the agency wrote. “Although health care providers with available inventory may continue to implant the BVS, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients.”

Earlier this year, Abbott halted global sales of its Absorb device, citing low sales. The company issued a statement yesterday, commenting on a 30-day study and four-year data presented at the annual Transcatheter Cardiovascular Therapeutics meeting.

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