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Boston Scientific’s Synergy Stent Narrowly Outperforms Biosensors’ Biomatrix NeoFlex In Danish Study

 
• By Reed Miller

Data from the 2,770-patient randomized SORT OUT VIII trial showed Boston Scientific’s Synergy everolimus-eluting stent is noninferior to Biosensor’s Biomatrix NeoFlex Biolimus-eluting stent for the endpoint of target lesion failure, but the procedure failure-rate was lower in the Synergy patients, which may have led to lower overall rates of myocardial infarction.

Synergy by Boston Science
Synergy thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent • Source: Boston Scientific

[Editor's note: Complete historical information on important medical device trial announcements is available from Informa’s MedDeviceTracker. Click here to request a demonstration. For an archive of previous Medtech Insight articles on medtech clinical trials, visit the Tracking Trials page.]

One-year results from SORT OUT VIII, a randomized trial comparing two metal drug-eluting coronary stents with biodegradeable polymers, demonstrate...

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FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 
• By Brian Bossetta

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

More from R&D

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 
• By Natasha Barrow

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market

 
• By Marion Webb

Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.