Cordis announced it has completed the acquisition of Flexible Stenting Solutions, a leading developer of innovative flexible peripheral arterial, venous and biliary stents on 12 March 2013.
Currently, Cordis markets the S.M.A.R.T. vascular stent worldwide. The addition of Flexible Stenting Solutions’ FlexStent self-expanding stent system provides Cordis with the opportunity to evolve the S.M.A.R.T. stent platform to address unmet needs in the treatment of peripheral artery disease. It also extends the company’s potential to expand therapeutic applications into below-the-knee and venous interventions.
“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, Cordis Corporation. “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 milestone in the company’s strategy to strengthen its position in the endovascular market. Recently Cordis received superficial femoral artery and proximal popliteal artery indications for the S.M.A.R.T.stent, the only stent approved in the US for iliac, superficial femoral artery and proximal popliteal artery vascular indications. In addition, Cordis offers endovascular technology platforms including percutaneous transluminal angioplasty balloons and chronic total occlusion crossing devices.
“The FlexStent system is a promising platform designed to optimise flexibility, fracture resistance and radial strength with predictable placement. We look forward to expanding our experience with this new technology platform,” said Thomas Zeller, director, Department of Angiology at Universitaets-Herzzentrum, Freiburg – Bad Krozingen, Bad Krozingen, Germany.
The FlexStent system received CE mark approval for the treatment of vascular disease (iliac, superficial femoral artery and popliteal) in January 2009. In the US, the device received 510(k) clearance by the FDA for the palliative treatment of biliary strictures associated with malignant tumors in September 2009. The FlexStent system is also being evaluated in an investigational device exemption (IDE) study to evaluate its safety and efficacy in the treatment of patients with atherosclerosis in the superficial femoral artery. Data from the OPEN trial are expected to support a premarket approval application requesting an expanded indication to treat superficial femoral artery disease in the USA.
“We are pleased to have the opportunity to learn more about the FlexStent system technology and its potential therapeutic applications for patients in the US beyond currently approved indications,” said William A Gray, director of Endovascular Services, Cardiovascular Research Foundation, New York, USA.