Medtronic wins expanded indications for Infuse bone growth protein

Medtronic (NYSE:MDT) said today it won expanded approval from the FDA for its Infuse bone growth protein implant, marking the second expansion for the implant over the past two years.

The Infuse implant contains the active ingredient rhBMP-2, a manufactured version of a bone growth protein normally present in the body. The Infuse device is designed for use with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease.

“Different spine patients can have very different surgical needs, so the more options surgeons have to combine a clinically-proven bone grafting technology like Infuse with different procedures and implants, the greater the likelihood of successful outcomes. This latest approval addresses some fairly common degenerative spine surgical correction needs,” Dr. Richard Hynes of Melbourne, Fla.’s B.A.C.K. Center said in a prepared statement.

With the new approval, the Infuse is cleared for use with additional PEEK spinal implants in oblique lateral interbody fusion and anterior lumbar interbody fusion procedures at a single level.

New indications for the Infuse bone graft include in OLIF 51 procedures with the Divergence-L interbody fusion device at a single level from L5 to S1, OLIF 25 procedures with Pivox oblique lateral spine systems at a single level from L2 to L5 and ALIF procedures with Divergence-L interbody fusion devices at a single level from L2 to S1.

“Infuse Bone Graft remains one of the most-extensively studied products in Spine that is commercially available today. The expanded approval with these PEEK devices for OLIF25, OLIF51, and ALIF procedures provide important options for surgeons and their patients,” Medtronic spine division prez Doug King said in a press release.

Earlier this month, Medtronic was dismissed as a defendant from a case claiming the use of the controversial Infuse spinal implant in an “off-label” lumbar procedure caused bone overgrowth and related pain.

The post Medtronic wins expanded indications for Infuse bone growth protein appeared first on MassDevice.

from MassDevice https://ift.tt/2HBs77r