Medtronic (NYSE:MDT) said today it won extended FDA approval for its Melody transcatheter pulmonary valve, now indicated for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed. The Fridley, Minn.-based company touted the Melody TPV as the 1st transcatehter pulmonary valve to win such an indication from the federal watchdog. “Unlike other transcatheter […]
Catheters
BioVentrix launches Revivent TC in China
BioVentrix said today it launched its Revivent TC transcatheter ventricular enhancement system in China, and that the device has been used in its 1st commercial procedure in the region. The Revivent system designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small titanium anchors along the heart’s outer […]
FDA warns of off-label balloon angioplasty to treat autonomic disorders
The FDA today released a safety communication concerning risks associated with off-label balloon angioplasty procedures intended to treat autonomic dysfunction, warning of serious health risks and a lack of supporting data. The procedure, called trans venous autonomic modulation, involves a catheter being threaded into a patients’ venous system where an attached balloon is inflated to […]
Keystone Heart, Venus Medtech ink Asian TAVR stroke partnership deal
Keystone Heart and Chinese heart valve maker Venus Medtech said today they inked a partnership deal covering China and other Asian markets. Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device. TriGuard is a cerebral embolic protection device designed to reduce the amount of […]
Abbott wins FDA nod for FlexAbility sensor-enabled ablation cath
Abbott (NYSE:ABT) said today it won FDA approval for its sensor-enabled FlexAbility ablation catheter designed for cardiac ablation procedures to treat atrial flutter. The sensor-enabled FlexAbility ablation catheter is the Abbott Park, Ill.-based company’s 1st designed to collect electrical current resistance and magnetic data to produce accurate mapping and assist in treating sites that trigger […]
AV Medical wins expanded FDA 510(k) for Chameleon PTA balloon cath
AV Medical Technologies said today it won expanded FDA 510(k) clearance for its Chameleon PTA balloon catheter designed for the infusion of diagnostic or therapeutic fluids. The Chameleon is designed to allow operators to inject diagnostic or therapeutic fluids through the catheter during procedures, whether the balloon is inflated or deflated and while maintaining wire […]
Study: Shifting to radial access PCIs could save hospitals $332m a year
A new study has shown that shifting 30% of femoral-access PCI procedures to transradial-access with same-day discharge for stable patients could save U.S. hospitals $332 million annually. Transradial-access PCI was also associated with fewer complications than the femoral-access approach, according to the study. “I believe this is a remarkable paper that has the [potential] to […]
7 disruptive innovations from medical device suppliers
Sometimes an innovation out of a contract manufacturer is truly disruptive when it comes to its potential for the medical device industry. Chris Newmarker, Managing Editor People sometimes make the mistake of viewing innovation as the product of a few geniuses and mavericks. But in fact, it is often the result of teamwork, as the […]
Teleflex wins FDA nod for Trapliner cath, sees shares rise on Street-topping Q4, FY2016 earnings
Teleflex (NYSE:TFX) today said it won FDA 510(k) clearance for its TrapLine Catheter and saw shares tick up upon the release of 4th quarter and full fiscal year 2016 earnings that beat expectations on The Street. The company’s TrapLine catheter was developed by Vascular Solutions, which Teleflex officially acquired last week. The TrapLiner is intended for use in conjunction with guide […]
Avenu Medical raises $13m
Vascular access system maker Avenu Medical has raised $13.1 million in a new round of equity financing, according to an SEC filing posted this week. The company has not yet stated how it plans to spend funds raised in the round or when it plans to close the round. Money in the round came from 77 unnamed […]
Medtronic launches DxTerity, TRA-line of radial access devices for PCIs
Medtronic (NYSE:MDT) today announced a slew of new percutaneous coronary intervention devices it added to its portfolio, including the DxTerity diagnostic angiography catheter line, the DxTerity TRA, InTRAkit transradial devices and the TRAcelet compression device. The Fridley, Minn.-based company said all of the items have already received FDA clearance in the US and CE Mark approval […]