Getinge (PINK:GETI B) said today it won expanded FDA clearance for its Sterizone VP4 sterilizer, now cleared to sterilize colonoscopes, gastroscopes and other multi-channel flexible endoscopes of up to 4 channels and 3.5 meters in length.
The Swedish medical device firm touted the win, saying that regulatory authorities are becoming more scrutinous of medical device reprocessing, particularly for colonoscopes and other complex minimally invasive surgical devices.
“With the new FDA-cleared indications for use, the Sterizone VP4 Sterilizer is the only validated and cleared low-temperature sterilizer available in the United States, Europe and Canada that can sterilize long and complex endoscopes. The Sterizone VP4 Sterilizer offers a practical and cost-effective way to safely sterilize devices previously processed with the less robust high-level disinfection process. The Sterizone VP4 Sterilizer raises the standards for infection control and patient safety. With these expanded indications, in addition to our current global efforts to commercialize in acute care facilities, we plan to introduce low-temperature sterilization into GI and endoscopy clinics, which are currently using only high-level disinfection,” surgical workflows prez Joacim Lindoff said in a press release.
The company said its Surgical Workplaces biz unit has exclusive global rights to distribute the next-gen sterilizer, which is manufactured by TSO3.
Maquet will distribute “a range” of Biotronik products designed to treat peripheral artery disease, including its Astron iliac self-expanding stent, Passeo percutaneous transluminal angioplasty balloon products and the line of Fortress reinforced sheaths, the companies said.
Wayne, N.J.-based Maquet said it will begin distribution of the products during the 1st quarter of this year.