The Pantheris catheter developed by Avinger takes the physician out of the radiation field. A clever catheter design lets cardiologists see inside arteries and precisely remove plaque from diseased tissue. The Pantheris catheter is safer than conventional radiation-guided procedures because it takes the surgeon out of the radiation field, and along with on-board optics, it […]
Catheters
Teleflex says Venture Cath recall is FDA Class I
Teleflex (NYSE:TFX) subsidiary Vascular Solutions today updated on a voluntary recall of its Venture Catheters over issues with excess material on the devices, saying that the FDA labeled it as a Class I recall, it’s most serious designation for recalls. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a […]
Study: Researchers create ‘ultrasound drill’ to attack thrombosis
Researchers have developed a new surgical tool which uses low-frequency intravascular ultrasound to break down blood clots which could cause deep vein thrombosis. The ultrasound “drill”, called that because it can be aimed directly ahead, could allow physicians to better target clots and reduce treatment time, according to researchers from North Carolina State University and […]
China’s Venus Medtech snaps up TAVR device developer InterValve
Chinese heart valve maker Venus Medtech said today it acquired U.S.-based transcatheter aortic valve replacement device developer InterValve for an undisclosed amount. Intervalve produces the V8 and TAV8 aortic valvuloplasty balloon catheters designed for performing percutaneous balloon angioplasty procedures and for pre and post-dilation during TAVR procedures. Venus said that the shape of the balloon helps […]
FDA clears AngioDynamics Solero MW tissue ablation system
AngioDynamics (NSDQ:ANGO) said today it won FDA 510(k) clearance for its Solero microwave tissue ablation system, with indications for the ablation of soft tissue during open procedures. The company’s Solero MTA system features a Solero MW generator with a 2.45 GH operating frequency and specially designed Solero MW applicator. The generator can power up to 140 […]
Teleflex’s Vascular Solutions recalls Venture catheters
Teleflex (NYSE:TFX) subsidiary Vascular Solutions is recalling its Venture line of catheters after discovering a manufacturing defect that could cause embolisms. “After an internal investigation, VSI has concluded there is a potential for excess material used to manufacture the catheter to be present within the inner lumen of the distal catheter tip. It is possible that the excess […]
OrbusNeich wins FDA nod for Sapphire II Pro, NC Plus balloon dilation caths
OrbusNeich said today it won FDA 510(k) clearance for its Sapphire II Pro and Sapphire NC Plus balloon dilation catheters and launched the devices in the US. The Hong Kong-based company’s Sapphire II Pro features a sub-zero tapered tip and an ultra-low profile for entry through tight lesions, as well as a proprietary XR balloon for crossability […]
Ex-Medtronic CEO Hawkins backs CardioNXT in $2m round
A former CEO of Medtronic (NYSE:MDT) and a well-known medical device industry veteran got in on a $2.1 million funding round for CardioNXT, which is developing new tools to treat atrial fibrillation. Ex-Medtronic chief William Hawkins III and Zyga CEO James Bullock led the round, joined by Piedmont Capital Partners and prior backer Solas BioVentures. […]
Boston Scientific, St. Jude Medical must face University of California patent suits
Boston Scientific (NYSE:BSX) and Abbott (NYSE:ABT) subsidiary St. Jude Medical must face lawsuits brought by the University of California alleging that their ablation catheters infringe a pair of patents covering atrial fibrillation treatments. The university’s regents sued the companies last October (a similar suit was brought against AtriCure (NSDQ:ATRC) the next month, according to court documents), accusing the companies […]
Avinger touts 2-year Pantheris study data
Avinger today released data from the pivotal vision study of its Pantheris system, touting high survivability and freedom from target lesion revascularization in patients treated with the system. The 89-patient Vision study aimed to evaluate the safety and effectiveness of its Pantheris directional atherectomy system which uses real-time intravascular imaging to remove plaque from diseased […]
AngioDynamics levels anti-trust suit against Bard over catheter tip locators
AngioDynamics (NSDQ:ANGO) said it leveled an anti-trust lawsuit against C.R. Bard (NYSE:BCR), alleging that the larger company illegally ties the sales of its peripherally inserted central catheters to its tip location devices. The lawsuit, filed today in the U.S. District Court for Northern New York, accuses Bard of maintaining its dominant position in the tip location market by only […]