Cook Medical this week released information on a select voluntary recall of its Bush DL and Bush SL ureteral illuminating catheter sets over issues with overheating. The Bloomington, Ind.-based company said it has received an increased number of reports of the proximal black component that connects to the distal transparent component overheating and melting, which could […]
Catheters
Tip-separation issues prompt recall of Merit Medical’s Prelude sheath introducer
The FDA today released data on a recall of Merit Medical‘s (NSDQ:MMSI) Prelude short sheath introducer over issues with the tip separating during the insertion process, and labeled the recall a Class 1. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health […]
Bio2 Medical raises $1.5m, looking for $6.5m more
Bio2 Medical raised $1.5 million in a new round of debt and option financing, according to an SEC filing posted this week. Money in the round came from 1 unnamed investor, with the date of the sale noted as March 18, according to the filing. The company has not yet stated how it plans to spend […]
Medtronic launches Arctic Front cryoablation PVI study
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in the Stop Persistent AF clinical trial of its Arctic Front Advance cardiac cryoablation catheter. The 225-patient, 12-month trial aims to explore the effectiveness and safety of pulmonary vein isolation-only treatments for patients with persistent atrial fibrillation using the Arctic Front Advance cryoablation catheter, the Fridley, […]
Cardiovascular Systems launches combined Diamondback 360, DES trial
Cardiovascular Systems (NSDQ:CSII) said today it enrolled the 1st patient in the Eclipse clinical trial of its Diamondback 360 coronary orbital atherectomy system. The St. Paul, Minn.-based company is looking to enroll 2,000 patients in the trial which aims to explore the use of the Diamondback 360 device for treating patients with severely calcified coronary lesions […]
QT Vascular raises $14m
QT Vascular said this week it inked a private placement deal with Gem Global Yield Fund for up to $14.3 million (SGD $20 million) over the next 30 months. In the funding agreement, Singapore-based QT Vascular will receive up to $7.2 million (SGD $10 million) over the next 30 months, with an option for an additional […]
Cardiac cath dev MedLumics raises $37m in Series B
Cardiac device developer MedLumics said today it raised $37 million (EU €34.4 million) in a Series B round of funding to support product and clinical development of its AblaView catheter designed to treat atrial fibrillation and other arrhythmias. The round was led by Edmond de Rothschild Investment Partners and joined by newly invested Seroba Life […]
Penumbra prices $99m offering
Penumbra (NYSE:PEN) said today that it priced a public offering worth nearly $99 million, not including an underwriter’s option worth nearly $15 million. Alameda, Calif.-based Penumbra makes a line of instruments designed for neurovascular and peripheral vascular procedures, including stroke revascularization, embolization and thrombectomy. The company said it plans to float 1.3 million shares at $76 […]
Corindus inks robotic R&D, training partnership deal with WakeMed
Corindus Vascular Robotics (NYSE:CVRS) said today it inked a partnership deal with WakeMed Health & Hospitals. Through the deal, the groups will develop a center which aims to advance clinical robotics research and train interventional cardiologists on robotic-assisted percutaneous coronary interventions using its CorPath GRX system, the Waltham, Mass.-based company said. “Our top priority is to provide […]
AngioDynamics wins CE Mark for Solero microwave tissue ablation system
AngioDynamics (NSDQ:ANGO) said today it won CE Mark approval in the European Union for its Solero microwave tissue ablation system, with indications for ablation of soft tissue during open, laparoscopic or percutaneous procedures. The Albany, N.Y.-based company’s Solero MTA system features a 2.45GHz microwave generator with an operating frequency up to 140 watts and a ceramic […]
Teleflex wins FDA nod for Twin-Pass torque dual access cath
Teleflex (NYSE:TFX) said today it won FDA 510(k) clearance for its Twin-Pass torque dual access catheter designed for the placement and exchange of guidewires into the coronary or peripheral vasculature. The Wayne, Penn.-based company said it has launched the Twin-Pass dual access catheter both in the US and internationally. “The Twin-Pass torque catheter builds on Vascular Solutions’ […]