FDA clearance received for reprocessing the Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter
WATERBURY, Conn., July 26, 2022 (GLOBE NEWSWIRE) — Northeast Scientific Inc., the pioneers in reprocessing single use peripheral vascular catheters, announced this week it has received FDA clearance for reprocessing the Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter. This is yet another first of its kind accomplishment for the Connecticut based company, as 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 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).
CEO and Founder, Craig Allmendinger discussed what this means to the company by saying, “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.”
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 OBL Physician and never compromise on patient safety.”
Director of Product Development, Matt Farley had this to say; “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.”
The company has said that it will have an additional announcement soon regarding when the 0.9mm OTW Turbo-Elite laser atherectomy catheter device will be available for sale.
With an unparalleled record for quality and safety across their 15 years of business, Northeast Scientific has reprocessed over 650,000 devices. Visit Smarthealth-care.com for more information.
Northeast Scientific Inc. Wins 510(k) for IVUS Catheter Reprocessing
WATERBURY, CT June 24, 2020 — Northeast Scientific Inc., this week announced it has received FDA clearance for reprocessing the .014 Digital IVUS catheter. This is the second 510(k) the Connecticut based company has been awarded for the reprocessing of the IVUS type catheter.
While crediting his team in their work addressing the FDA requirements to win the 510(k), CEO Craig Allmendinger went on to say; “By adding the .014 IVUS to our existing portfolio of products, we are positioned to be the key resource for any OBL Physician focused on keeping costs down while never compromising on patient safety”.
“Adding the .014 in conjunction with the ongoing R&D projects we are working on for other devices, Northeast Scientific is going to continue to separate itself as the world leader in reprocessing for the peripheral vascular market”, closed Allmendinger.
The company has said that it will have an additional announcement soon regarding when the .014 device will be available for sale.
With an unparalleled record for quality and safety across their 15 years of business, Northeast Scientific has reprocessed over 650,000 devices. Visit Smarthealth-care.com for more information.
Northeast Scientific Celebrates Medical Device Remanufacturing Success
WATERBURY, CT February 4, 2019 — Northeast Scientific, Inc. (NES), known for its advanced medical device remanufacturing successes for more than 13 years, continues its business growth and development by bringing its marketing, sales and customer service in-house.
NES announced on February 4th that it will begin closely managing all customer interaction for the delivery of its remanufactured VNUS ClosureFAST® Catheters, RF Stylets, remanufactured Philips Volcano® IVUS diagnostic catheters and other products to the medical market. Heretofore, Vascular Solutions, Inc. (owned by Teleflex, Inc.) had managed all sales and customer service in the U.S. for NES and helped introduce NES remanufactured devices to more than 500 medical practices, including vein centers and OBLs (Office-based labs) throughout the country.
As of February 4th, 2019 customers will now work directly with NES for purchasing, billing, and service.
“The success of our relationship with VSI/Teleflex has put NES in a strong financial position and allowed us to make this move,” said NES’ CEO Craig Allmendinger. “The market has developed as well and high-end device reprocessing like we provide has become a standard part of a physician’s practice.”
NES has sold over 310,000 remanufactured ClosureFAST® RF ablation devices since 2012 with superior safety results. The RF Ablation Stylet, introduced mid-2018, is experiencing the same results.
NES remanufacturing allows doctors to use a so-called ‘single-use device’ or SUD several times, with some practices saving well over $100,000 annually with just the remanufactured ClosureFAST® RF Ablation catheter alone.
Remanufacturing prolongs the useful life of millions of devices annually, reducing the tonnage of metal and plastic waste that finds its way to landfills or to the incinerator each year.
Northeast Scientific, Inc. (NES), in Waterbury, Connecticut, is registered with the U.S. Food and Drug Administration as both a reprocessor of single-use medical devices and as a manufacturer. Founded in 2005, NES received its first FDA clearance in 2007, has added new products to its reprocessing suite and is developing several additional remanufactured products for the vascular specialty. NES is ISO 13485: 2016 Certified.
Northeast Scientific Receives 510K Clearance on Reprocessed RF Stylet
WATERBURY, Conn., March 28, 2018 (GLOBE NEWSWIRE) — Northeast Scientific, Inc. (NES), known for its advanced medical device reprocessing capability, received another 510K clearance from the FDA on 27 March, this time for the RF Stylet manufactured by Covidien, a division of Medtronic.
This FDA clearance gives NES the green light to reprocess and market the stylet. The device, originally manufactured by VNUS, is used in vessel and tissue coagulation, including treatment of incompetent (i.e., refluxing) perforator and tributary veins.
“The proprietary systems we have built for the ClosureFast RF Ablation Catheter are just a natural fit for the RF Stylet,” said NES CEO, Craig Allmendinger.
NES has sold over 250,000 ClosureFast RF Ablation devices since 2012 with superior safety results.
“The Stylet will get the same rigorous treatment as ClosureFast,” Allmendinger said. “The market has come to love the efficiency of our reprocessing service and they will get the same with this device.”
Reprocessing under an FDA 510K allows doctors to use a single-use device several times and reduce their costs. The NES focus on reprocessing more complex and costly devices provides even greater savings for end-users. Some NES customers save over $100,000 annually with just the Reprocessed ClosureFast RF Ablation catheter alone.
Reprocessing also prolongs the useful life of millions of devices, reducing the tonnage that finds its way to landfills or to the incinerator each year.
Reprocessed VNUS ClosureFast Catheters – 6 Years of Superior Performance
WATERBURY, Conn., March 06, 2018 (GLOBE NEWSWIRE) — Northeast Scientific Inc. (NES) has released 5-year results proving that the use of their reprocessed medical devices is safe, effective and smart. NES has successfully supplied 250,000 reprocessed VNUS ClosureFast RF Ablation Catheters with no adverse events and exceptional physician savings.
Proven Performance
Less than 0.25% (less than 1 in 400) of NES reprocessed devices are returned for performance failure.
NES inspects every single device, not just a sampling like most OEMs.
Any user who is not happy with the device for any reason is given full credit.
Excellent Safety Record
NES has supplied the reprocessed device for more than 5 years with NO ADVERSE EVENTS.
Search for the keyword “closurefast” on the FDA MAUDE database to see all adverse events involving the ClosureFast catheter.
Smart Doctors
Search online for doctors who use the NES reprocessed catheter and consult with other physicians: Reprocessing makes strong financial sense for the practice. Some save more than $100,000 each year on devices alone.
Simple math
Doctors pay on average 35% less for the reprocessed VNUS ClosureFast Catheter, and the savings compound with increased use of NES devices.
35% savings with a device that is proven safe and effective by doctors across the country.
Come see the operation in Waterbury, CT. Call anytime with any questions 203.756.2111.
Watch a video about NES here https://nescientific.com/about-us/
See what else NES does here – www.worldpace.org