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Angiotech initiates european trial examining the Vascular Wrap™ paclitaxel-eluting mesh for dialysis patients with end-stage renal disease |
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30 May 2007 |
Angiotech Pharmaceuticals, Inc., a global specialty pharmaceutical and medical device company, today announced the initiation of a European study evaluating the safety and efficacy of the Vascular Wrap™ paclitaxel-eluting mesh (“Vascular Wrap™”) after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular (AV) access.
VANCOUVER, Canada | May 29, 2007 | Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced the initiation of a European study evaluating the safety and efficacy of the Vascular Wrap™ paclitaxel-eluting mesh (“Vascular Wrap™”) after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular (AV) access.
“Patients with end-stage renal disease today face the high probability that their AV graft will fail within the first year of use. The Vascular Wrap™ product has the potential to save these dialysis patients from the further health and financial burdens of repeated surgeries and additional hospitalizations,” said Dr. Eric Chemla, coordinating investigator of the study based at St. George’s Healthcare NHS Trust in London, UK.
“We believe that the Vascular Wrap™ product will be a key catalyst for building out an Angiotech-branded, vascular franchise. We expect that the results from this European study and the ongoing U.S. pivotal trial will form the groundwork for expanding the potential indications for the Vascular Wrap™ technology,” said Dr. William Hunter, President and CEO of Angiotech.
The European (AV) study will involve approximately 198 patients at 20 centres in Europe. The first patient was enrolled by Dr. Ali Bakran at the Royal Liverpool University Hospital. Within one year following vascular access surgery, the patency of the Vascular Wrap™ combined with an ePTFE vascular graft will be compared to a control group of patients who receive the standard of care, which is an ePTFE vascular graft alone.
In March 2007, Angiotech launched a similar pivotal trial in the United States, which is also designed to evaluate the safety and efficacy of the Vascular Wrap™ after surgical implantation with an ePTFE vascular graft in the upper extremity for AV access.
In November 2006, Angiotech reported results from its European first-in-man study examining the safety and clinical performance of the Vascular Wrap™ when used to treat patients suffering from advanced peripheral arterial disease (PAD) in their lower limbs. Based on the strength of this two-year data, Angiotech submitted an application for a CE Mark for its Vascular Wrap™ paclitaxel-eluting mesh / ePTFE vascular graft combination product for this indication. Upon receipt of a CE Mark, Angiotech would commence commercialization of its Vascular Wrap™ product in the EU and certain other countries outside of the United States.
About the European (AV) Study
The European (AV) study is a multi-centre, randomized, single-blind study to assess the safety and effectiveness of the Vascular Wrap™ after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular (AV) access. It is expected that results from this study will serve as a base of European experience for CE Mark submission, along with supporting data from the U.S. pivotal trial.
About Angiotech
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
SOURCE: Angiotech Pharmaceuticals, Inc.
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