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TCT 2016: Three-Year ABSORB II Data Fail To Show The Hoped-For Long-Term Benefit Of Bioresorbable Stent

 
• By Reed Miller

The data, presented Oct. 30 at the TCT Conference in Washington, DC, also showed higher rates of device-related adverse events including myocardial infarction with Abbott’s Absorb bioresorbable stent than a metallic drug-eluting stent, but the study was not powered to show differences in clinical endpoints, so this adverse safety signal must be evaluated in future clinical trials.

In what will no doubt be a disappointment to Abbott Laboratories Inc., three-year follow-up data from the ABSORB II trial did not show that Abbott’s Absorb GT1 everolimus-eluting biodegradable poly(L-lactide) scaffold improved vasomotor reactivity or late-lumen loss compared to Abbott’s Xience metallic everolimus eluting stent.

The results, the first long-term data on a randomized trial of a bioresorbable stent, were presented by Patrick Serruys of...

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• By Marion Webb

Volta Medical received a labeling expansion for its AF-Xplorer mapping software to treat A-fib, which provides the clinical evidence needed to broaden US access. The company hopes for FDA clearance for its improved second-gen AF-Xplorer II software.

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 
• By Brian Bossetta

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Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
• By Natasha Barrow

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

SS Innovations’ SSI Mantra 3 Poised To Challenge Da Vinci In Robotic Surgery Market

 
• By Marion Webb

SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.

More from Device Area

Home-Testing Added To UK National Cervical Cancer Screening Program

 
• By Natasha Barrow

NHS England will offer at-home cervical cancer self-testing kits to people who are overdue for routine screening by six months. The Department of Health and Social Care identified four HPV collection and testing combinations with highest accuracy.

New Openwater Data Shows Promise For AI-Driven Optical Rapid Stroke Detection

 
• By Shubham Singh

Openwater is currently focusing on EMS applications of its AI-powered stroke detection technology, both in-hospital and prehospital, such as in ambulances and urgent care centers.

ADA 2025: Tandem Becomes Abbott’s Fourth Partner In Push To Advance Dual Sensor CGM Strategy

 
• By Marion Webb

Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.