Biotronik announced that it received CE mark approval and completed the first European implant of its latest insertable cardiac monitor (ICM). The BioMonitor IV features AI capabilities for false positive reduction. The AI cuts false positives for AFib, bradycardia, tachycardia and pause. According to Biotronik, its SmartECG reduces 86% of false detections across all major […]
Structural Heart
Shockwave Medical has positive Reducer data
Shockwave Medical (Nasdaq:SWAV) announced positive six-month and long-term real-world outcomes for its Reducer technology. Investigators presented data at the American College of Cardiology (ACC) Scientific Sessions in Atlanta. Results included six-month data from the full REDUCER-I population and interim long-term follow-up results out to three years. According to Shockwave, results confirm the positive real-world outcomes […]
Abiomed reports positive Impella CP results in treating cardiogenic shock
Johnson & Johnson’s Abiomed shared data supporting the use of its Impella CP in patients who had a heart attack with cardiogenic shock. The data was presented at the American College of Cardiology conference and published it in the New England Journal of Medicine. The study evaluated patients who had a heart attack with ST-elevation […]
Medtronic says Evolut TAVR outperformed Edwards Sapien in head-to-head trial
Medtronic today announced data from a head-to-head trial backing its Evolut TAVR system against the Edwards Sapien platform. The medtech giant presented results from the one-year SMART trial at the American College of Cardiology Annual Scientific Session. It simultaneously published the study results in The New England Journal of Medicine. SMART evaluated Evolut and Sapien […]
Abbott warns on electromagnetic interference in some Aveir leadless pacemakers
Abbott recently issued an urgent field safety notice warning physicians that some Aveir leadless pacemakers may have electromagnetic interference. The Abbott Park, Illinois-based company warned that a subset of Aveir VR LSP112V devices manufactured with firmware version 19.05.00 have the potential for electromagnetic interference that could cause an inadvertent mode change. So far, the company […]
Silk Road launches next-gen transcarotid neuroprotection system
Silk Road Medical (Nasdaq:SILK) announced that it launched its EnRoute Plus transcarotid neuroprotection system. The transcarotid artery revascularization (TCAR) system builds upon the company’s previous EnRoute system, launched just last month. It delivers smoother arterial sheath insertion, greater flow precision and a simplified prep experience for surgical teams. The system delivers all this while maintaining […]
FDA approves Abbott TriClip TEER system
Abbott announced today that the FDA granted approval for its first-of-ts-kind TriClip transcatheter edge-to-edge repair (TEER) system. The expected approval comes after a February vote by an FDA panel that confirmed the system’s benefits outweighed its risks. Abbott designed TriClip to treat tricuspid regurgitation (TR), or a leaky tricuspid valve. Delivered through a vein in […]
JenaValve publishes positive data for its TAVR system
JenaValve announced today that it published new results supporting the use of its transcatheter aortic valve replacement (TAVR) system. The company published results from its ALIGN-AR pivotal trial in The Lancet. The trial evaluates the Trilogy valve in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation. JenaValve presented positive study results from ALIGN-AR last […]
FDA approves next-gen Evolut TAVR system from Medtronic
Medtronic announced today that the FDA approved its next-generation Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The FDA’s approval covers the treatment of symptomatic aortic stenosis. Medtronic says the latest version of the Evolut valve maintains the performance of the Evolut platform with a design that facilitates coronary access. Evolut FX+ TAVR offers larger […]
Protembis raises $32.6M, adds Shockwave exec to board
Cardiovascular medical device maker Protembis announced today that it completed a $32.6 million (€30 million) Series B financing round. The Aachen, Germany-based company plans to use the funds to support enrollment for its PROTEMBO FDA investigational device exemption (IDE) trial. The trial evaluates the company’s embolic protection technology. European VC investors, including Segulah Medical Acceleration, […]
Abbott wins CE mark for insertable cardiac monitor
Abbott announced today that it received CE mark approval for its Assert-IQ insertable cardiac monitor (ICM). The ICM provides a new option for diagnostic evaluation and long-term monitoring in people experiencing abnormal heartbeats. It can detect hard-to-spot irregularities in heartbeats and help physicians determine the best treatment course. Assert-IQ received FDA clearance in May 2023, […]