|Medtronic Announces Approval and Launch of Japan's First DBM Bone Grafting Product for Spine and Orthopedic Procedures|
Grafton(TM) DBM Product Will Provide More Options for Spine and Orthopedic Surgeons in Japan
DUBLIN and TOKYO - February 28, 2019 - Medtronic plc (NYSE:MDT) announced today the Japanese launch of the Grafton(TM) Demineralized Bone Matrix (DBM) bone grafting product for spine and orthopedic procedures. Grafton DBM is the first and only demineralized bone matrix product available in Japan, the world's second largest market for spinal medical devices. Due to its long clinical history, proven performance, and safety, Grafton DBM received PMDA approval in August 2018.
Grafton DBM is a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities). With the proprietary D-MIN process, Grafton consistently scores high osteoinductivity*, which is an important part of bone fusion. Grafton DBM is the most utilized and scientifically-studied* DBM brand on the market with over 25 years of clinical history.
"Our unmatched combination of biologic therapies, services and expertise help surgeons meet the needs of each unique patient," said Jacob Paul, senior vice president and president of the Spine division, which is part of the Restorative Therapies Group at Medtronic. "Grafton is an important option within our comprehensive, market-leading biologics portfolio, and we're excited that surgeons in Japan now have access to this clinically-proven osteoinductive bone graft product."
Grafton has been used in more than 1.5 million procedures around the world*. The product is commercially available in the U.S., Japan, Korea, Australia, Latin America, the Middle East, and parts of Europe.
Grafton is comprised of multiple forms, each with unique handling characteristics. The product forms launching in Japan include Grafton Putty, Grafton Matrix, and Grafton Matrix Strip.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
* Data on file