Cordis currently markets the S.M.A.R.T. vascular stent worldwide. Cordis officials hope the addition of FSS’ FlexStent self expanding stent system will provide the company with the opportunity to evolve the S.M.A.R.T. stent platform to address unmet needs in the treatment of peripheral artery disease (PAD). It also extends the company’s potential to expand therapeutic applications into below-the-knee and venous interventions. An estimated 27 million people in Europe and North America suffer from PAD.
“Cordis continues to identify opportunities to enhance its expanding portfolio of less-invasive treatment options to address the needs of patients suffering from vascular disease worldwide,” said Shlomi Nachman, company group chairman of Cordis. “This acquisition will enable Cordis to provide clinicians more options to meet their evolving therapeutic needs and to strengthen our leadership position in the treatment of vascular disease.”
This acquisition marks another move in the company’s strategy to strengthen its position in the endovascular market. Cordis received superficial femoral artery (SFA) and proximal popliteal artery indications for the S.M.A.R.T. stent from European regulatory bodies in January 2009. According to the company, it is the only stent approved in the United States for iliac, SFA and proximal popliteal artery vascular indications.
“The FlexStent system is a promising platform designed to optimize flexibility, fracture resistance and radial strength with predictable placement,” said Thomas Zeller, M.D., Ph.D., director of the angiology department at Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. “We look forward to expanding our experience with this new technology platform.”
The FlexStent system is CE marked for sale in Europe. In the United States, the device received 510(k) clearance by the Food and Drug Administration for the palliative treatment of biliary strictures associated with malignant tumors in September 2009. The system also is being evaluated in an investigational device exemption study to evaluate its safety and efficacy in the treatment of patients with atherosclerosis in the SFA, or SFA disease. Data from the open trial are expected to support a premarket approval application requesting an expanded indication to treat SFA disease in the United States.
“We are pleased to have the opportunity to learn more about the FlexStent system technology and its potential therapeutic applications for patients in the U.S. beyond currently approved indications,” said William A. Gray, M.D., director of endovascular services at the Cardiovascular Research Foundation, New York, N.Y.
Gray and Zeller are compensated for their services as consultants to Cordis.