Cordis Acquires Flexible Stenting Solutions

Agreement expands treatment options for advanced peripheral artery disease


March 21, 2013

March 21, 2013 — Cordis Corp. announced it has completed the acquisition of Flexible Stenting Solutions Inc. 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 (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 alone 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, Cordis Corp. “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 (SFA) and proximal popliteal artery (PPA) indications for the S.M.A.R.T. stent, the only stent approved in the United States for iliac, SFA and PPA vascular indications. In addition, Cordis offers endovascular technology platforms, including percutaneous transluminal angioplasty (PTA) balloons and chronic total occlusion (CTO) crossing devices.

“The FlexStent System is a promising platform designed to optimize flexibility, fracture resistance and radial strength with predictable placement. We look forward to expanding our experience with this new technology platform,” said Prof. Dr. Thomas Zeller, director of the angiology department at Universitaets-Herzzentrum, Freiburg — Bad Krozingen, Bad Krozingen, Germany.

The FlexStent system received CE mark approval for the treatment of vascular disease (iliac, SFA and popliteal) in January 2009. In the United States, the device received 510(k) clearance from the U.S. Food and Drug Administration (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 SFA, or SFA disease.[1]  Data from the OPEN trial are expected to support a premarket approval (PMA) 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, Cardiovascular Research Foundation.

Terms of the acquisition were not disclosed. Gray and Zeller are compensated for their services as consultants to Cordis.

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1. The FlexStent system is approved for investigational use only in the United States for the treatment of patients with atherosclerosis in the SFA. This product is not available for commercial sale in the United States for this investigational use. The FlexStent system is available for commercial sale in the United States for the palliative treatment of biliary strictures associated with malignant tumors, pursuant to the 510(k) clearance received in September 2009.