Cook Medical today announced more sizes and locations for the Advance Serenity hydrophilic PTA balloon catheter product line. It's now possible for U.S. and Canadian interventionalists to use Advance Serenity for below-the-knee and above-the-knee procedures to treat patients with peripheral artery disease (PAD), according to Cook Medical. In … [Read more...] about Cook Medical has more hydrophilic PTA balloon catheter options
Teleflex recall of Arrow catheter system is Class I
The FDA today designated Teleflex's recall of its Arrow Endurance extended dwell peripheral catheter system as Class I, the most serious type of medical device recall. The recall involved 262,016 devices distributed from October 26, 2018, to May 10, 2023, according to the FDA. Teleflex and its Arrow International subsidiary have reported 83 … [Read more...] about Teleflex recall of Arrow catheter system is Class I
The top catheter innovation news stories of 2023 — so far
The world of catheter innovation has already seen remarkable strides this year— with some of the most promising medtech delivered into the body via catheter-based procedures. Think of improved ablation for treating AFib, coronary intravascular lithotripsy to combat coronary artery disease, and more. Here, we've highlighted the top five … [Read more...] about The top catheter innovation news stories of 2023 — so far
Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott (NYSE: ABT) today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world's first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott's EnSite X EP System, enabling physicians to visualize heart anatomy more … [Read more...] about Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Medtronic moves DiamondTemp catheter manufacturing to Ireland
Medtronic (NYSE:MDT) is letting go of 59 workers at a facility in Sunnyvale, California, according to a notice filed with the state. The California Employment Development Department says it received the WARN notice on April 7. In a statement shared with MassDevice, Medtronic said it seeks effectiveness and efficiencies to drive growth. "As we … [Read more...] about Medtronic moves DiamondTemp catheter manufacturing to Ireland
Getinge penalized in EU over life support system problems
The EU notified body DEKRA out of Germany has temporarily suspended the CE certificates for Getinge HLS and PLS sets, starting this month. The Swedish medtech company announced the suspension on Feb. 23. Health providers use the HLS and PLS for extracorporeal respiratory and/or cardiovascular support. Getinge had already announced potential … [Read more...] about Getinge penalized in EU over life support system problems
How Alpine Laser created its medical tube cutting workstation
A partnership with Omron Automation Americas enabled Alpine Laser to create what it describes as an easy-to-support, modular machine for cutting stainless steel medical tubing. Alpine Laser (Bloomington, Minnesota) recently launched its medical-tube-cutting Medicut Pro. Alpine Laser describes the Medicut Pro as a purpose-driven and ultra-fast … [Read more...] about How Alpine Laser created its medical tube cutting workstation
Alleviant Medical raises $75M for no-implant heart failure treatment
Alleviant Medical has raised $75 million to support a global pivotal trial of its catheter-delivered interatrial shunt to treat heart failure. The FDA provided the Austin, Texas–based company with an Investigational Device Exemption for the clinical trial in November 2022. Researchers have designed the ALLAY-HF study to demonstrate the safety … [Read more...] about Alleviant Medical raises $75M for no-implant heart failure treatment
Surmodics is laying off roughly 60 workers
Surmodics (Nasdaq: SRDX) announced a restructuring that includes cutting 13% of the workforce at the Eden Prairie, Minnesota-based IVD tech developer. In its most recent annual report, Surmodics listed a headcount of 447, which means the layoff could involve nearly 60 workers. The cost-reduction plan will save roughly $10 million to $11 million … [Read more...] about Surmodics is laying off roughly 60 workers
Cirtec Medical acquires QMD Precision Components
Cirtec Medical (Brooklyn Park, Minnesota) announced today that it has acquired QMD's Precision Components business. The financial terms of the deal were not disclosed. The move comes amid continued consolidation in the medical device industry's contract manufacturing and supplier space. QMD’s Precision Components business specializes in the … [Read more...] about Cirtec Medical acquires QMD Precision Components
