BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]
Millar wins expanded CE Mark for Mikro-Cath pressure catheter
Millar has received a CE Mark approval expansion for its Mikro-Cath Pressure Catheter. The expansion now includes airway and intra-compartmental pressure measurements. The new expansion will give physicians the opportunity to make improvements in respiratory care while delivering a continuous monitoring technique for measuring compartment pressure and diagnosing acute compartment syndrome at onset. Mikro-Cath can be […]
FDA clears Contego Medical’s Vanguard IEP peripheral balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function. “Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues […]
J&J’s Biosense Webster launches Heliostar multi-electrode ablation cath trial
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study. The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation. The […]
Zeus: Try our heat shrink products at no cost
Polymer extrusion and tubing company Zeus seems to be taking a page out of the sales playbook of software companies and direct marketers. Zeus (Orangeburg, S.C.) is telling medical device companies interested in switching to its peelable heat shrink tubing that they can initially try it out for free. Get the full story on our sister […]
FDA clears Innovative Health to reprocess major manufacturers’ catheters
Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster. The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, […]
Millar ends CD Leycom distribution agreement
Millar said today that it is discontinuing its exclusive North American distribution agreement with CD Leycom, maker of the clinical Inca pressure-volume (PV) loop system. Officials at Houston-based Millar – a pressure sensors and medical device contract manufacturing company – plan to focus more on the company’s OEM division, which integrates pressure sensors based on microelectromechanical systems […]
Abbott launches FlexAbility cath ventricular tachycardia ablation trial
Abbott (NYSE:ABT) said yesterday that it launched a study aiming to evaluate ablation treatments for patients with ventricular tachycardia, touting it as the first such trial of its kind. In the trial, dubbed the Less-VT study, investigators will explore the safety and effectiveness of ablation with the Chicago-area medtech giant’s FlexAbility ablation catheter in treating monomorphic […]
Abiomed shares slide despite Impella CP trial success
Abiomed (NSDQ:ABMD) shares fell approximately 13.1% yesterday despite the company announcing positive results from a pilot trial of its Impella CP heart pump that will clear the way for a pivotal that could nearly double the device’s total addressable market. The company announced on Sunday that a pilot study of its Impella CP, used to […]
Cardiovascular Systems enters Chinese market through OrbusNeich deal
Cardiovascular Systems (NSDQ:CSII) said today that it successfully launched its Diamondback 360 coronary orbital atherectomy system in China as part of a distribution agreement with OrbusNeich. St. Paul, Minn.-based Cardiovascular Systems said that the first patient has already been treated with the device in Hong Kong. “Orbital Atherectomy is simple to use. It is a very controllable […]
Trial shows BD balloon compares well with angioplasty for CLI
BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee. The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb […]
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