Abbott's Absorb GT1 Is First FDA-Approved Absorbable Coronary Stent

 
• By Reed Miller

Following the near-unanimous advice of its advisory panel, the US FDA approved Abbott Laboratories’ Absorb GT1 everolimus-eluting biodegradable poly(L-lactide) scaffold, making it the first bioresorbable coronary stent commercially available in the US.

On July 5, the FDA approved Abbott Laboratories Inc.'s PMA for Absorb GT1 for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions no longer than 24 mm with a reference vessel diameter between 2.5 mm and 3.75 mm. Absorb is also contraindicated for patients who cannot tolerate a regimen of post-procedural antiplatelet drugs and patients with hypersensitivity to everolimus or any of the stent's component materials.

As a condition of approval, Abbott has agreed to sponsor a prospective post-approval study enrolling up to 3,000 US patients....

More from Approvals

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
• By Elizabeth Orr

NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.

More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.