The TOTAL across crossing catheter, which recently won regulatory approval from E.U. regulators, is designed to help improve blood flow in the legs, especially in challenging below-the-knee vessels. The catheter features a "spiral cut stainless steel hypotube construction" and tapered tip designed to help navigate the device through narrow regions.
"The TOTAL across crossing catheter expands our portfolio of medical devices for the interventional treatment of peripheral artery disease," endovascular therapies president and senior vice president Tony Semedo said in prepared remarks. "It’s a prime example of our focus on developing lesion-specific solutions and our ongoing commitment to addressing BTK lesions specifically. We are excited to be introducing this new device in Europe and look forward to bringing it to the United States in the near future."
The new catheter is part of a growing portfolio of below-the-knee treatment devices, including 3 new products that Medtronic plans to launch over the next 2 years. The company is also looking to advance its Compete Self-Expanding vascular stent, the IN.PACT suite of drug-eluting balloons and a few families of
percutaneous transluminal angioplasty balloon catheters.
Medtronic earlier last year closed enrollment in the U.S. arm of a study evaluating its IN.PACT Admiral drug-eluting balloon, hoping to use results from the 181-patient study to support a bid for premarket approval. The device maker in August filed the 1st module of the PMA application, with commercial launch slated for 2015.