Acutus Medical said today it launched a trial of its AcQMap high resolution imaging and mapping system designed to guide ablation procedures for treating persistent atrial fibrillation. 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 images of the […]
Catheters
FDA puts Acclarent’s Aera Eustachian tube balloon in Class II
The FDA today said it reclassified Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent’s Aera Eustachian tube balloon to a Class II device. The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the balloon is inflated to open up a pathway for mucus and […]
Medtronic wins FDA nod for lower-profile HawkOne atherectomy device
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for a new lower profile version of its HawkOne directional atherectomy system, designed for treating patients with peripheral artery disease. The Fridley, Minn.-based company’s HawkOne is a directional atherectomy device designed to treat severely calcified lesions in the blood vessels of the lower extremities. The device […]
FDA adds diagnostic indication for Avinger’s Pantheris atherectomy device
Avinger (NSDQ:AVGR) said today it won expanded indications from the FDA for its Pantheris Lumivascular atherectomy system, now cleared for diagnostic imaging as well as treatment for peripheral artery disease. The Redwood City, Calif.-based company touted the win, saying its Pantheris is the 1st and only image-guided atherectomy device to receive clearances as both a diagnostic […]
Stryker recalls Boston Scientific Guider guide cath
Stryker‘s (NYSE:SYK) neurovascular division this month released a recall notice for Boston Scientific‘s (NYSE:BSX) Guider guide catheter it distributes over issues with an incomplete seal that could lead to blood loss. Both companies are coordinating to enable the recall and return of affected products, according to the recall release. No deaths or adverse events were […]
Medtronic touts cryoballoon cost savings data from Fire & Ice trial
Medtronic (NYSE:MDT) today released new economic analysis data from the Fire and Ice trial comparing cryoballoon catheter ablation with radiofrequency ablation, touting advantages of cryoballoon treatment over RF. Data from the trial was presented at the Asia Pacific Heart Rhythm Society’s Scientific Sessions in Seoul. Primary results from the trial were published in The New […]
St. Jude wins FDA nod, launches PressureWire X FFR system
St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its PressureWire X guidewire fractional flow reserve measurement system and launched the device in the U.S. The PressureWire guidewire system is designed to measure arterial blood pressure by calculating fractional flow reserve associated with stenosis in patients with coronary artery disease. The next-gen version of the device […]
Vascular Solutions recalls Twin-Pass dual access caths
Vascular Solutions (NSDQ:VASC) said yesterday it initiated a nationwide recall of its Twin-Pass dual access catheters due to a potential for excess material in the catheter that could dislodge and pose a risk for embolism. The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse […]
CardioFocus launches HeartLight in U.S.
CardioFocus said yesterday it launched its HeartLight endoscopic ablation system in the U.S., touting that the 1st commercial procedure with the device had been performed at New York City’s Mount Sinai Hospital. The HeartLight system allows electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural […]
Medtronic wins FDA nods for TrailBlazer peripheral support cath
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system. The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as […]
Phenox touts pREset thrombectomy device trial data
German device maker Phenox today released data from a study of its pREset thrombectomy device, touting high rates of positive clinical outcomes and freedom from severe neurological deficits. The 100-patient trial examined a total of 109 acute intracranial vessel occlusions treated with the pREset device, looking to evaluate the efficacy of the device, overall safety […]