Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, announced recently in a press release that it has received US Food and Drug Administration (FDA) clearance for reprocessing the Philips Spectranetics 0.9mm over-the-wire Turbo-Elite laser atherectomy catheter.
This is the first time the FDA has awarded a 510(k) clearance for reprocessing this type of atherectomy catheter.
The device is used to treat peripheral arterial disease (PAD) and emits high-energy ultraviolet light to vaporise blockages inside the vessels.
Chief executive officer and and founder Craig Allmendinger discussed what this means to the company, saying, “It is validating to receive this clearance from the FDA after all the work our team undertook to meet the standards of earning a 510(k). The team at the FDA pushed us hard, and rightfully so, to prove that our methods and processes created an equivalent device to the original after reprocessing.”
He went on to say, “There is no doubt now that what we are doing is helping redefine the medical device landscape as we add another device type to our reprocessing portfolio. As we continue to expand our device types and reach, we look to further help the office-based lab physician and never compromise on patient safety.”
The company has said that it will have an additional announcement soon regarding when the 0.9mm over-the-wire Turbo-Elite laser atherectomy catheter device will be available for sale.