MagAssist announced today that it received breakthrough device designation from the FDA for its NyokAssist ventricular assist device. The interventional VAD provides mechanical circulatory support for high-risk percutaneous interventions. It features a 9 Fr insertion size with a foldable catheter pump to facilitate insertion and removal. This reduces the vascular access and closure processes. Its […]
Catheters
Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
Teleflex announced today that it released its Arrow ErgoPack complete kits with hemodialysis and larbe bore catheters in the U.S. Wayne, Pennsylvania-based Teleflex launched this update to streamline insertion workflow for clinicians. The company also says it provides more options to suit their particular needs. Get the full story at our sister site, Medical Tubing […]
FDA deems latest Abiomed Impella recall Class I
Abiomed, a Johnson & Johnson unit, issued another recall for some of its Impella heart pumps. This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge […]
Medtronic’s third recall of Mahurkar hemodialysis catheters is Class I
The FDA has labeled the Medtronic recall of some Mahurkar hemodialysis catheters as Class I, the most serious kind. Medtronic is recalling its Mahurkar 12 Fr high-pressure triple lumen acute dialysis catheters in 20 cm length with curved extensions due to occlusions in the tip of the catheter. The company said the source of the […]
Shockwave Medical increases offering price to $650M
One day after proposing a private offering worth proceeds of $500 million, Shockwave Medical announced a price increase for that offering. The Santa Clara, California-based calcified cardiovascular disease treatment developer announced its private offering yesterday, Aug. 10. That announcement covered convertible senior notes due in 2028. It featured an additional option to purchase, within 13 […]
Baird Medical submits disposable microwave ablation needle for FDA clearance
Baird Medical announced today that it submitted its disposable microwave ablation (MWA) needle system to the FDA for 510(k) clearance. Guangzhou, China-based Baird submitted the system in search of an indication for the treatment of soft tissue microwave ablation. The FDA’s Center for Devices and Radiologic Health (CDRH) accepted the submission last month. Baird’s system […]
Shockwave Medical announces $500M private offering
Shockwave Medical (Nasdaq:SWAV) announced today that it intends to offer $500 million in convertible senior notes due in 2028. Santa Clara, California-based Shockwave plans to offer these notes to qualified institutional buyers. The offering also includes an option to purchase, within 13 days of first issuance, up to an additional $75 million in notes. The […]
FDA approves POLARx cryoablation system from Boston Scientific
Boston Scientific announced today that it received FDA approval for its POLARx cryoablation system. The new system received an indication for the treatment of patients with paroxysmal AFib. It features the POLARx FIT cryoablation balloon catheter. This device enables two balloon sizes (28 mm and 31 mm) all in one catheter. Cryoablation, a minimally invasive […]
Acutus posts Q2 beats, expects AcQBlate ablation catheter approval by end of 2023
Acutus Medical (Nasdaq:AFIB) reported positive second-quarter results, with some future plans that got analysts excited. Shares of AFIB rose 0.8% at 68¢ apiece in mid-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 2.1%. BTIG analysts Marie Thibault and Sam Eiber maintained a “Buy” […]
FDA approves multiple AFib ablation devices from Biosense Webster
Johnson & Johnson’s Biosense Webster announced today that the FDA approved several products in its cardiac ablation portfolio for zero fluoroscopy workflow. Products that received approval include the ThermoCool SmartTouch SF catheter, the most commonly used ablation catheter for radiofrequency ablation. The portfolio’s approved products also include the standard ThermoCool SmartTouch and Carto Vizigo bi-directional […]
FDA grants breakthrough nod for water vapor ablation therapy from Francis Medical
Francis Medical announced that the FDA granted breakthrough device designation for its Vanquish water vapor ablation therapy. The Minneapolis-based company designed its proprietary, minimally invasive Vanquish therapy to treat prostate, kidney and bladder cancer. Vanquish water vapor technology applies the thermal energy stored in drops of water to deliver targeted treatments to cancerous tissue. It […]