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Cardiovascular Catch-Up: Medtronic And Edwards Make Headlines At TCT Conference

 
• By Reed Miller

The first half of November was full of cardiovascular device news, led by clinical trial results from renal denervation and transcatheter aortic valve trials presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

3d rendered medically accurate illustration of the tricuspid valve
• Source: Shutterstock

Medtronic announced the start of the SPYRAL AFFIRM study, which is evaluating the long-term safety, efficacy, and durability of renal denervation with Medtronic’s Symplicity system in “real-world” patients with uncontrolled hypertension.

The study was granted an investigational device exemption in June and began in early November with the enrollment of the first patient at the Piedmont Heart Institute in Atlanta. The study will include about 1,000 patients at 100 sites globally

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• By Marion Webb

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AAOS 2025 Orthopedic Roundup: J&J Velys UKA, Stryker Mako 4, Materialise, Canary Medical

 
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LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
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More from R&D

No Knife, No Burn, Just Bubbles: HistoSonics Hits 90% Tumor Control In #HOPE4Liver Trial, Eyes IPO Timing

 
• By Marion Webb

HistoSonics, which developed a noninvasive technology to destroy tumor cells, reports 90% local tumor control at 12-month follow-up in the #HOPE4Liver Trial. The Edison System, cleared by the US FDA in late 2023, is also being evaluated for kidney and pancreatic tumors. CEO Mike Blue said the medtech is financially secure but watching public markets as it considers an IPO.

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

 
• By Brian Bossetta

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.

First Liver Cancer Surveillance Test In Five Years Receives FDA Breakthrough Status

 
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Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.