A Medical Device Daily
Interventional Spine (formerly Triage Medical; Irvine, California) reported that its European notified body has granted CE mark approval for the company’s Percutaneous Dynamic Stabilization (PDS) system for the early-stage treatment of spinal disorders.
CEO Walter Cuevas said, “This approval enables us to launch the PDS system in European markets during 2007. Dynamic stabilization has become a rapidly growing procedure in Europe and we believe that the PDS system has significant clinical and patient advantages over the dynamic stabilization devices currently available.”
He added, “This approval also gives us the impetus to both initiate a series of clinical studies in Europe to broaden the application of the PDS System to an even wider group of patients and move forward to begin our first pivotal clinical study in the U.S.”
The company said it believes the PDS system is the only procedure available that can provide dynamic stabilization of the spine via a percutaneous access puncture. It said that all other dynamic stabilization systems and procedures require a major or minimally invasive surgical incision to provide pain relief to patients with degenerative spinal disc disease.
Dynamic stabilization is an alternative to medical management, corticosteroid injections and, when indicated, invasive surgical fusion therapies, to the approximately 500,000 patients on a worldwide basis who suffer from degenerative disc disease of the spine.
The procedure provides relief from the pain of degenerative disc disease while maintaining far greater motion compared to patients of spinal fusion surgery, the company said.
Third-party experts have estimated that the market for dynamic stabilization products will grow to more than $500 million within the next five years.
In addition to providing the least-invasive approach to dynamic stabilization, the results from the company’s initial pilot clinical study indicate that the PDS system provides greater relief from pain for individuals suffering from spinal disc disease than any other dynamic stabilization product or procedure.
Interventional Spine said it intends to conduct a series of extensive clinical trials and continue to prove the clinical value.
The company said it changed its name from Triage Medical this month to “more effectively communicate the clinical and business strategic emphasis of the company.”
In addition to the PDS system, Interventional Spine also has both FDA market clearance and CE mark approval for its PLS system, which allows the least-invasive method of providing fixation of the vertebral structures following conventional spinal fusion procedures.
Rather than needing a surgical incision to implant the required vertebral fixation devices, the PLS system can accomplish such fixation with one small percutaneous-access puncture. This improves patient compliance, recuperation time and lowers the cost of such procedures, according to the company.
Interventional Spine’s products for the treatment of degenerative spinal disc disease as well as a broad range of orthopedic applications are based upon its Clasp and Teleport Access technologies.
Biotherapeutics firm opens European offices
Talecris Biotherapeutics (Research Triangle Park, North Carolina) has established Talecris Biotherapeutics GmbH (Frankfurt, Germany) to serve as its European headquarters.
The new European subsidiary represents the second expansion in 2006 for the biotherapeutics manufacturer, completing the next regional phase in the company’s ongoing global expansion plan.
“Our expansion into Europe signifies another key milestone demonstrating the strategic growth we have planned for our company,” said CEO and President Alberto Martinez, MD. “We established Talecris Europe to deliver tailored sales and support services to our European customers, and our European leadership team brings the knowledge, experience and dedication to do exactly that.”
Commenting on Talecris’ establishment of a European presence, Claus Vogelmeier, MD, of the Division of Pulmonary Diseases at University Hospital Marburg (Marburg, Germany), said, “We are pleased to continue working with Talecris, now in Europe, to help physicians identify and treat patients with alpha-1 antitrypsin deficiency, also known as genetic emphysema. Their commitment to invest in research projects and patient and professional support programs will continue to strengthen our ability to improve patient outcomes.”
With the new German offices, Talecris said it is now positioned to work closely with physicians and their patients to improve clinical care of primary immune deficiency patients.
In business for just 20 months, Talecris already has achieved annual sales of more than $1 billion and has grown to employ more than 3,000. The company supplemented its business with the acquisition of Precision Pharma Services, which provides additional fractionation capacity, and by acquiring 58 plasma collection centers from International BioResources to complete the vertical integration of the business.
England is going smoke-free
All enclosed public places and workplaces in England will become smoke-free beginning July 1, 2007, according to Health Secretary Patricia Hewitt, who said, “This is a triumph for public health and a huge step forward for health protection. Thousands of people’s lives will be saved and the health of thousands more protected”
She added, “Smoke-free legislation will protect everyone from the harm of secondhand smoke when working, socializing and relaxing and will provide a more supportive environment for smokers who wish to give up.”
In making the announcement, Hewitt said the scientific and medical evidence “is clear — second-hand smoke kills, causing a range of serious medical conditions including lung cancer, heart disease and sudden infant death syndrome in children. This legislation will help to prevent the unnecessary deaths caused every year from second-hand smoke, and recognizes that there is absolutely no safe level of exposure.”
She said that never has a health issue created such debate in Parliament, across government, through the business and the voluntary sectors, and among the general public. “And the more it has been debated, the more people have responded and pushed the limits to ensure that enclosed public places and workplaces in England will become wholly smoke-free.”
The Health Secretary also launched a new Smokefree England campaign that will help the country’s 3.7 million businesses — including nearly 200,000 pubs, bars, restaurants and other leisure outlets — prepare for the implementation of the legislation.