Michael Barbella, Managing Editor09.01.22
Northeast Scientific Inc., has received U.S. Food and Drug Administration (FDA) clearance for reprocessing the Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter. The clearance is reportedly the first awarded by the FDA for reprocessing this type of atherectomy catheter.
The device is used to treat peripheral arterial disease (PAD) and emits high energy ultraviolet light to vaporize blockages inside the vessels. This laser catheter is one of the most used modalities for this common procedure with treatments done in acute care settings, surgical centers as well as in the Office Based Lab (OBL).
“It’s 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,” CEO and Founder Craig Allmendinger said. “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 OBL Physician and never compromise on patient safety.”
“We knew undertaking the Turbo-Elite device would be a difficult task as no-one had ever reprocessed a laser-based atherectomy device to date. Our team at all levels, from R&D to the product development team to the technicians helping do the work on the validations all have credit in making this product be cleared for reprocessing,” Product Development Director Matt Farley said.
With an unparalleled record for quality and safety across its 15 years of business, Northeast Scientific has reprocessed more than 650,000 devices.
The device is used to treat peripheral arterial disease (PAD) and emits high energy ultraviolet light to vaporize blockages inside the vessels. This laser catheter is one of the most used modalities for this common procedure with treatments done in acute care settings, surgical centers as well as in the Office Based Lab (OBL).
“It’s 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,” CEO and Founder Craig Allmendinger said. “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 OBL Physician and never compromise on patient safety.”
“We knew undertaking the Turbo-Elite device would be a difficult task as no-one had ever reprocessed a laser-based atherectomy device to date. Our team at all levels, from R&D to the product development team to the technicians helping do the work on the validations all have credit in making this product be cleared for reprocessing,” Product Development Director Matt Farley said.
With an unparalleled record for quality and safety across its 15 years of business, Northeast Scientific has reprocessed more than 650,000 devices.