FDA asks Medtronic for more info on bone graft productby Martin Moylan, Minnesota Public Radio
St. Paul, Minn. — Medtronic says U.S. health regulators have told the company they can't consider approving a new bone graft product without additional information.
The product is designed to use a protein to stimulate bone growth and relieve low back pain.
Analysts say Medtronic has been looking to the product to help boost its spine business, which accounts for 22 percent of sales. Medtronic spokeswoman Marybeth Thorsgaard said the company hopes approval will come after further discussions with the FDA.
"The letter has specific questions that it wants Medtronic to address and we've been given the opportunity by the FDA to provide further information relevant to those questions and we're actively addressing them," she said.
Medtronic says an FDA advisory panel concluded there is a reasonable assurance that the product is safe and effective and its benefits outweigh its risks. But there were concerns expressed about cancer cases in some patients.