A Medical Device Daily

Medtronic Sofamor Danek (Memphis, Tennessee) said it has received European approval for a spinal fusion indication for the InductOs product containing recombinant human bone morphogenetic protein (rhBMP-2) that promotes new bone growth, or bone regeneration.

With the new indication, the surgically implanted InductOs is now available for use with the company’s LT-CAGE device for single-level anterior lumbar spinal fusion in adults with degenerative disc disease who have had at least six months of non-operative treatment for this condition.

Medtronic said that with InductOs, patients can avoid the pain and complications associated with treating one aspect of degenerative disc disease by eliminating the surgery needed to harvest bone from the patient’s hip, as is traditionally done in spine fusion procedures.

RhBMP-2 is a naturally occurring protein that results in the formation of new bone when implanted in specific, targeted areas in the spine by causing cells to differentiate into bone-forming cells.

The company said that degenerative disc disease affects as much as half of the population aged 40 and older and can cause a variety of symptoms, ranging from back pain to nerve root pathology and spinal cord compression. Spinal fusion surgery, commonly used to treat degenerative disc disease, stabilizes the vertebrae to eliminate the pain caused by a degenerated spinal disc.

InductOs was originally approved by the European Commission in September 2002 for use in the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation. It is used to increase the probability that tibial fractures will heal faster and reduce the need for additional surgeries to achieve complete healing.

Medtronic Sofamor Danek, the spinal business of Medtronic (Minneapolis), said that RhBMP-2 has been used in treating tens of thousands of U.S. patients suffering from lumbar degenerative disc disease since its approval by the FDA nearly three years ago (Medical Device Daily, July 11, 2002).

The product, which is known as Infuse Bone Graft in the U.S., is licensed to Medtronic by Wyeth (Madison, New Jersey). RhBMP-2 was co-developed by Wyeth and Yamanouchi Pharmaceutical (Tokyo).

UK investing 20M in DXA scanners

Persons with suspected osteoporosis will be diagnosed more rapidly and treated more quickly thanks to a 20 million investment in scanning equipment and service improvements for the UK’s National Health Service (NHS).

A cash injection of 3 million this year will quickly increase the NHS’s capacity to provide this diagnostic service through the use of DXA scanners,which measure bone density. An additional 17 million will be made available over three years to build NHS capacity to improve access and reduce waiting times.

Health Minister Stephen Ladyman said, “Osteoporosis is a devastating, debilitating condition which increases the risk of fracture when an older person falls. Each year 14,000 people die in the UK as a result of an osteoporotic hip fracture.”

He said that improving access to scanning “is part of our pledge to have an integrated falls service in place by [this month]. We spend 1.7 billion a year treating fractures caused by falling; these integrated services reduce the risk of falls by half.”

Ladyman said 400,000 older people visit Accident & Emergency units each year as a result of falls. “They can suffer serious injury and also lose their confidence and mobility,” he said. “We are determined that older people stay active, healthy and retain their independence through exercise.”

Professor Ian Philp, national clinical director for older people, said, “This additional investment will increase the capacity and responsiveness in scanning for osteoporosis among [those who fall] and reduce their risk of subsequent fractures.”

Terry Eccles, chief executive of the National Osteoporosis Society, hailed the announcement, saying that the NHS funding “will ensure that areas that still need to purchase DXA scanners will now be able to do so.”

Stephen to aid Sensitron in Europe

Sensitron (San Mateo, California) said that Garry Stephen, founding shareholder of UK-based Cobalt Partners Ltd., also will head Sensitron’s international business development for Europe.

Sensitron has developed the careTrends Wireless Bridge system. The company said the system minimizes transcription errors and eliminates lag time between the reading, capture and documentation of clinical data, accomplished by communicating vital signs and other data from wirelessly enabled point-of-care medical devices at the bedside.

Stephen’s primary role for Sensitron will be to qualify, introduce and help the company close a business relationship with strategic channel partners. He also will assist with market intelligence and research about the respective markets.

“With his extensive experience in finance and business development globally, he can help Sensitron find the right channel partners throughout Western Europe,” said Rajiv Jaluria, president and CEO of Sensitron. “He has already helped us locate a reputable channel partner for Southeast Asia and Australia.”

Privately held Sensitron is backed by and in partnership with NewMarket Technology.