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CRT 2018: Late-Breakers Feature Sapien MR, Selution DCB, Low-Risk TAVR, and Radial Access PCI

 
• By Reed Miller

The late-breaking trials presented at the 2018 CRT Conference in Washington, DC, March 3-6 included new clinical data on novel drug-eluting coronary stents, endovascular peripheral vascular interventions, and transcatheter heart valve devices, plus a major trial comparing transfemoral and transradial coronary interventions.

Washington DC Capitol dome detail with waving american flag
CRT is an annual four-day conference featuring new data and vascular intervention technology held in Washington, DC

The first-in-human study of Edwards' Sapien M3 transseptal transcatheter mitral valve replacement device shows it is a feasible option for patients with severe mitral regurgitation who would be at high risk during open mitral-valve surgery. John Webb of St. Paul's Hospital in Vancouver presented the results of the first 10 cases with Sapien M3 during a late-breaking trial-session at the CRT meeting on March 5.

Sapien M3 is a combination of Edwards' successful 29 mm Sapien 3 transcatheter aortic valve and a unique nitinol docking...

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More from Clinical Trials

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database

 
• By Natasha Barrow

Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.

Roche Eyes 2026 FDA Nod After CE Mark For pTau181 Test To Boost Global Alzheimer’s Diagnosis

 
• By Shubham Singh

The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

More from R&D

Siemens Healthineers Mitigates Headwinds With ‘Value-Add Structural Changes’

 
• By Natasha Barrow

Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."

CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.