Renal Dynamics said it launched a post-market study of its Redy renal denervation device for treating hypertension, after winning CE Mark approval for the device last November. Zug, Switzerland-based Renal Dynamics, which is owned by the Hobart Group, said the 1st patient in the trial was successfully treated at Novosibirsk, Russia’s Meshalkin State Research Institute of Circulation Pathology. […]
Catheters
Mitralign drums up $40m Series E for heart valve repair devices
Mitralign said today that it raised a Series E round worth nearly $40 million for a pair of heart valve repair devices, its namesake Mitralign annuloplasty system and the Trialign device for tricuspid repair. The Tewksbury, Mass.-based company said it plans to use some of the proceeds to pursue regulatory nods for the Trialign device in the […]
WinMed looks to license or sell VariSoft guidewire
WinMed is looking for a buyer for the VariSoft guidewire developed by founder & CEO Ed Winters, inking a deal with medical device incubator Hatch Medical to broker the sale or licensing of the device. Read the full story at our sister site, Medical Design & Outsourcing.
Acutus Medical wins CE Mark for AcQMap image & mapping system
Acutus Medical said today it won CE Mark approval in the European Union for its AcQMap high resolution imaging and mapping system designed for use with its AcQMap catheter. The company’s AcQMap imaging and mapping system is designed to detect and display standard voltage-based and higher resolution charge-source maps, and is able to generate real-time, 3D […]
CardioFocus readies HeartLight’s U.S. coming-out party at HRS 2016
Pre-market approval from the FDA in hand, CardioFocus is readying for a coming-out ball of sorts for its HeartLight cardiac visualization and ablation device at this week’s annual meeting of the Heart Rhythm Society in San Francisco. Chairman Paul LaViolette told MassDevice.com that Marlborough, Mass.-based CardioFocus is planning a selective U.S. launch for HeartLight starting […]
UPDATE: Cook Medical recalls all 4m Beacon Tip catheters
UPDATED May 5, 2016, with comment from Cook Group president Pete Yonkman. The catheter recall that’s been bedeviling Cook Medical since last year grew last month as the company recalled all lots of catheters using its Beacon Tip locating technology, but the company expects to have replacement catheters on the market within the next several weeks. The move […]
Boston Scientific wins FDA nod for Rhythmia cardiac mapping and ablation catheters
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for a pair of ablation catheters that use the 3D cardiac mapping technology it bought from Rhythmia Medical back in 2012. Marlborough, Mass.-based Boston Scientific said the federal safety watchdog gave the green light to its IntellaNav XP and IntellaNav MiFi XP mapping and ablation […]
Merit Medical looks to capitalize on rival Cook’s recall
Merit Medical (NSDQ:MMSI) chief Fred Lampropoulos said his company is ready to take advantage of the worldwide recall of rival Cook Medical‘s central catheter sets. The FDA in March slapped the Cook recall with a Class I label, denoting the risk of serious injury or death. It covers Cook’s single lumen central venous catheter sets and trays, single lumen […]
Boston Scientific chides EU docs for unsupervised Lotus valve implants
Boston Scientific (NYSE:BSX) today released a field safety notice warning after an investigation identified that a “number of sites” had been performing procedures with the Lotus Valve System without an appropriately trained field clinical specialist. The Marlborough, Mass.-based company said that the presence of a Boston Scientific field clinical specialist is required unless a site is designated […]
Medtronic touts multi-trial In.Pact Admiral data
Medtronic (NYSE:MDT) today released a bevy of new data from clinical studies of its In.Pact Admiral drug coated balloon designed for treating peripheral artery disease. The Fridley, Minn.-based released data from 3 different studies of its In.Pact Admiral DCB at the 2016 Charing Cross Symposium meeting in London, including 1-year results from a chronic total occlusion imaging […]
Medtronic launches Barrx 360 radiofrequncy ablation cath in US
Medtronic (NYSE:MDT) said today it launched its Barrx 360 Express radiofrequency ablation balloon catheter designed to treat Barrett’s esophagus. The Barrx 360 Express is a self-adjusting circumferential RFA catheter designed for RFA treatments to remove diseased tissue in the esophagus while minimizing injury to health esophageal tissue. The Fridley, Minn.-based company said the treatment has been […]