Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a 6 French version of its HawkOne directional atherectomy device designed for treating peripheral artery disease. The Fridley, Minn.-based company’s device is designed as a treatment for PAD which can operate both above and below the knee. “Directional atherectomy is an established […]
Catheters
BD wins expanded FDA 510(k) clearance for PleurX cath system
Becton Dickinson & Co. (NYSE:BDX) said today it won expanded FDA 510(k) clearance for its PleurX catheter system. The PleurX catheter system is now cleared for use in treating non-malignant recurrent pleural effusions etiologies, including congestive heart failure and cardiogenic effusions, the Franklin Lakes, N.J.-based company said. “Our research found that the Pleurx catheter provided palliation […]
CardioFocus launches next-gen HeartLight Exalibur balloon trial
CardioFocus said today it launched a clinical trial of its next-generation HeartLight Excalibur balloon device designed for pulmonary vein isolation procedures. The Marlborough, Mass.-based company said the next-gen device incorporates the balloon design from its HeartLight endoscopic ablation system alongside a new advanced feature set intended to improve speed and the magnitude of target tissue contact during […]
Abbott launches St. Jude Medical’s Ensite Precision cardiac mapping
Abbott (NYSE:ABT) yesterday said it launched the EnSite Precision cardiac mapping system it acquired when it paid $25 billion for St. Jude Medical earlier this month. The commercial launch also included the sensor-enabled Advisor FL circular mapping catheter, Abbott said. The system, which won 510(k) clearance from the FDA in December 2016, was used for […]
Avinger shares drop on Q4 prelims
Avinger (NSDQ:AVGR) saw shares prices drop -12% today after it released preliminary financial results for the 4th quarter, missing analysts’ expectations on Wall Street. The Redwood City, Calif.-based company said it expects a total revenue of $4.7 million, up 62% over Q4 2015 but down -11% from the 3rd quarter. Revenue from disposable devices is expected to be $3.7 million, […]
Lombard wins Japanese clearance for IntelliFlex LP delivery device for Aorfix stent graft
Lombard Medical Technologies (NSDQ:EVAR) said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its Intelliflex low profile delivery system for the Aorfix endovascular stent graft. The Oxfordshire, England-based company said it will initiate a commercial launch of the device in Japan once it receives reimbursement approval, expected some time next month. […]
Cook Medical launches Motion 2-in-1 hybrid guidewire
Cook Medical said today it launched the Motion 2-in-1 hybrid wire guide designed for urology procedures. The newly launched device features both a nitinol access guidewire with a Teflon fixed core safety guidewire, the Bloomington, Ind.-based company said. Cook Medical touted the hybrid device, saying the combined guidewires allow clinicians to “streamline” their procedures by reducing […]
FDA expands clearance for Avinger’s Lightbox L250 vascular imaging console
Avinger (NSDQ:AVGR) said today that it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after Pantheris Lumivascular atherectomy procedures in patients with peripheral artery disease. “The ability to obtain an accurate and real-time measurement from inside a diseased vessel is […]
AtriCure warns on tip detachment risk with Cobra Fusion cardiac ablation device
AtriCure (NSDQ:ATRC) in September warned doctors of the risk that the tip of its Cobra Fusion cardiac ablation catheter could dislodge and separate from the device. The Cobra Fusion device is designed to deliver both bipolar and monopolar energy to the ablation site. The device also uses suction to gently pulls tissue out of the path of circulating blood […]
Sanovas launches SinuGeniX sinus treatment subsidiary
Sanovas recently announced the launch of SinuGeniX, a wholly-owned subsidiary focused on treating chronic sinusitis with the company’s RegENT sinus treatment system. The newly-launched subsidiary won’t just supply a single tool for treating chronic sinusitis, which affects over 28 million Americans, but a suite of technologies, Sanovas CEO and system co-inventer Larry Gerrans told MassDevice.com in […]
Researchers show drug, catheter combo speeds up labor delivery
Using the drug misoprostol in combination with a Foley balloon catheter to induce labor can lead to a speedier delivery, with women delivering several hours earlier than either method alone, according to research from the University of Pennsylvania. The team’s work was published in Obstetrics & Gynecology. Nearly 1 million women who deliver in the U.S. […]