News: Paradigm BioDevices, Inc. Completes 25,000th Procedure with the QuickDraw MIS Bone Harvester™ and Reports Positive Independent Clinical Findings
October 19, 2016
ROCKLAND, Mass.–(BUSINESS WIRE)–Paradigm BioDevices, Inc. announced today that it completed its 25,000th case with its proprietary MIS bone grafting system. The QuickDraw MIS Bone Harvester is a percutaneous and/or MIS access system for obtaining autogenous iliac crest bone graft for fusion procedures.
“Cancellous autograft remains the gold standard because it contains osteoconductive architecture, osteogenic stem cells and osteoinductive signaling factors.” said Michael O’Neill, President & CEO of Paradigm. “Not all autografts or bone graft materials meet this high standard. Iliac crest graft is widely accepted as the best bone graft available for fusion and we are able to obtain it through a minimal incision which is driving our success.”
An independent study with the QuickDraw MIS Bone Harvester found that 67% of patients could not tell they had a bone graft harvest, of the remaining only 14% of those were confident. The clinicians concluded, “(we) describe a minimally-invasive procedure to harvest iliac crest bone graft. Pain at the site was either non-existent or mild enough that patients were unable to accurately define their graft site.”
Paradigm BioDevices will be launching a new single use sterile kit version of the system at the North American Spine Society next week in Boston. The company expects CE clearance later this year and will expand its marketing and distribution efforts for sale of products outside the US.
About Paradigm BioDevices
Paradigm BioDevices, Inc. is an ISO 13485-2012 certified manufacturer of minimally-invasive orthopedic and spinal instrumentation and a master US national distributor of spinal fusion technologies. The company is a Boston-based privately-held organization founded in 1997. For more information, visit http://www.paradigmbiodevices.com.