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 […]
Catheters
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 […]
Access Vascular’s HydroPICC shows positive results in reducing clot formation and failures
Access Vascular this week announced positive results from a study of its HydroPICC catheter. Billerica, Massachusetts-based Access Vascular designed the device to help reduce the most common and costly complications that are associated with vascular access procedures, including infection, thrombosis and phlebitis. The HydroPICC is constructed of a hydrophilic biomaterial with Mimix technology. A peer-reviewed […]
Abbott has a serious recall involving its Amplatzer delivery sheath
The FDA today said an Abbott recall involving its Amplatzer steerable delivery sheath is Class I, its most serious level. Launched in the U.S. in April 2022, the Amplatzer sheath delivers Abbott’s Amplatzer Amulet left atrial appendage occluder. Competing against Boston Scientific’s Watchman, Amplatzer Amulet provides complete occlusion in order to reduce the risk of […]
J&J’s Biosense Webster launches AFib mapping catheter
Johnson & Johnson’s Biosense Webster announced today that it launched the Optrell mapping catheter with TrueRef technology. Irvine, California-based Biosense Webster designed Optrell as a high-density diagnostic catheter powered by its Carto 3 system. It features small electrodes arranged in a fixed array formation. These provide high-definition electrophysiological mapping of complex cardiac arrhythmia cases. Optrell […]
Boston Scientific to close California facility, lay off 52 employees
Boston Scientific filed its intention to reduce its workforce amid a California facility closure. The facility closure means a reduction of 52 jobs, adding to the 120 positions cut in Texas earlier this year. This marks the latest round of layoffs in medtech as the industry attempts to navigate difficult economic conditions. MassDevice has reported […]
Teleflex completes enrollment in percutaneous coronary intervention study
Teleflex announced today that it completed patient enrollment in its prospective multicenter Ringer PTCA study. Ringer PTCA is one of two clinical studies evaluating Teleflex’s novel Ringer perfusion balloon catheter. The trial enrolled patients across seven leading complex percutaneous coronary intervention (PCI) centers in the U.S. and Canada. Dr. Kathleen Kearney of the University of […]
Endologix completes first procedures using Detour system to kick off U.S. launch
Endologix announced today that the first patients underwent a procedure using its Detour system since it received FDA approval. The FDA approved Detour for use in percutaneous transmural arterial bypass (PTAB) to treat peripheral arterial disease (PAD) last month. This initial procedure marks the official start of the company’s targeted market release of Detour in […]