Ra Medical Systems (NYSE:RMED) last week began a voluntary recall of its Dabra laser system single-use catheters due to a calibration problem. The Dabra laser system has experienced inconsistent performance because of catheters that fail to calibrate before procedures, which can result in a temporary delay, according to an SEC filing. Ra Medical’s review of the […]
Catheters
Ex-BD engineer accused of stealing trade secrets
A former BD R&D engineer is scheduled to go on trial in Salt Lake City on January 6, 2020, accused of stealing trade secrets in order to compete with the company. The U.S. Attorney’s office in Utah’s central district indicted Minh Quang Hoang in May 2018 on 11 counts of stealing trade secrets related to […]
Access Vascular raises $6m for HydroPICC device
Access Vascular said today that it raised $6 million from new and existing investors for the HyrdoPICC device it developed, earmarking the proceeds for the launch of. HydroPICC, a peripherally inserted central catheter, is made of a proprietary material that’s designed to inhibit the formation of blood clots. It won 510(k) clearance from the FDA […]
Cardiovascular Systems wins FDA approval for ViperWire Advance atherectomy guidewire
Cardiovascular Systems (NSDQ:CSII) said today that it won pre-market approval from the FDA for a new ViperWire Advance coronary guidewire for orbital atherectomies using its Diamondback 360 device. The new guidewire features a floppy, shapeable tip designed to navigate complex anatomies and reduce wire bias, the St. Paul, Minn.-based company said. “We remain committed to expanding […]
Baylis Medical touts first MitraClip procedure with VersaCross catheter
Baylis Medical said today that it successfully completed the first Abbott (NYSE:ABT) MitraClip procedure with Baylis’ VersaCross transseptal solution catheter. VersaCross is a left-heart access device designed with an atraumatic radio frequency-tipped pigtail wire to achieve access and then serve as an exchange wire, reducing the number of exchanges throughout the procedure. The MitraClip is designed […]
Access Vascular logs GPO win with Premier contract
Access Vascular said today that it won a group purchasing agreement for a breakthrough technology with Premier for the HydroPICC peripherally inserted central catheter. Bedford, Mass.-based Access Vascular’s HydroPICC is indicated for reduced thrombus accumulation. The catheter body is composed of biocompatible biomaterial, instead of the standard polyurethane as the material for the body. The […]
FDA IDs first devices for expedited 510(k) clearance review
The FDA has released draft guidances for the first four types of devices it will evaluate under its expedited Safety and Performance-Based Pathway to 510(k) clearance. They are: Conventional foley catheters. Cutaneous electrodes for reporting purposes. Orthopedic non-spinal metallic bone screws and washers. Spinal plating systems. Developers of these types of devices will no longer […]
LimFlow wins FDA nod for pDVA trial in chronic limb-threatening ischemia
LimFlow said today that it won an investigational device exemption from the FDA for a pivotal trial of its catheter-based intervention for a severe form of peripheral artery disease. LimFlow’s percutaneous deep vein arterialization device is designed to re-route blood flow from a blocked artery through the venous system to deliver oxygenated blood to the […]
V-Wave’s interatrial shunt lands another breakthrough nod from FDA
V-Wave said yesterday that it won FDA breakthrough device designation for its interatrial shunt for pulmonary arterial hypertension, marking the second time in less than a month that the company has earned a breakthrough nod. The PAH shunt is designed to be placed in the heart through a catheter inserted via a vein in the […]
Medtronic recalls certain balloon catheters
Medtronic is voluntarily recalling certain balloon dilation catheters that have proven difficult to remove from patients’ bodies. The recall affects a subset of the company’s Euphora and Solarice semi-compliant rapid exchange balloon dilatation catheters manufactured from February 27, 2019, through July 31, 2019, according to a letter sent to customers. Medtronic said that some of […]
Cardiac Dimensions touts Carillon TMVR study
Cardiac Dimensions today touted a clinical study of its Carillon mitral contour system in treating the primary cause of functional mitral regurgitation (FRM) in patients with heart failure. Carillon is a right heart transcatheter mitral valve repair (TMVR) device designed to treat FRM in patients with mitral regurgitation grades of 2+, 3+ and 4+ in […]