Cordis Corporation, a worldwide leader in the development of interventional vascular technology, has completed the acquisition of Flexible Stenting Solutions, Inc., a leading developer of innovative flexible peripheral arterial, venous and biliary stents.
Currently, Cordis markets the SMART Vascular Stent worldwide. The addition of Flexible Stenting Solutions’ FlexStent Self Expanding Stent System provides Cordis with the opportunity to evolve the SMART 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 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 (SFA) and proximal popliteal artery (PPA) indications for the SMART Stent, the only stent approved in the US for iliac, SFA and PPA vascular indications. In addition, Cordis offers market-leading endovascular technology platforms including percutaneous transluminal angioplasty balloons and chronic total occlusion 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 Department Angiology at Universitaets-Herzzentrum, Freiburg - Bad Krozingen, Bad Krozingen, Germany.
The FlexStent System received European CE Mark approval for the treatment of vascular disease (iliac, SFA and popliteal) in January 2009. In the US, the device received 510(k) clearance by the 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. Data from the OPEN Trial are expected to support a Premarket Approval (PMA) application requesting an expanded indication to treat SFA disease in the US.
“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, MD, Director of Endovascular Services, Cardiovascular Research Foundation, New York.
Terms of the acquisition were not disclosed. Dr Gray and Prof. Dr Thomas Zeller are compensated for their services as consultants to Cordis.
Peripheral artery disease (PAD) is caused by the build-up of fatty substances that collect and adhere to the linings of the arteries, in a process known as atherosclerosis. The build-up causes the internal lining of the artery to thicken, narrowing the artery and limiting blood flow to vital tissues and organs. Commonly affected arteries include those located in the legs, arms, neck and kidneys.
Cordis Corporation, part of the Johnson & Johnson family of companies, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with physicians worldwide to treat millions of patients who suffer from vascular disease.