Terumo Aortic today announced the launch of the company’s global surgical graft study known as PANTHER. This study is a prospective and retrospective, multi-centre, multi-arm, post-market study of the company’s comprehensive range of knitted and woven surgical grafts and cardiovascular patches.
The PANTHER study is the first of its kind in the world and represents a significant commitment to the extensive collection of data on the company’s open surgical grafts and cardiovascular patches across a large number of geographies. One of the key aims of the study is to demonstrate the long-term clinical performance of open surgical grafts.
The study will start with over 30 sites at leading healthcare institutions primarily in Europe and North America. There are five defined cohorts as outlined in the study protocol with each group representing a specific product family; approximately 900 patients will be enrolled and followed for more than 10 years. Future expansion of the study to include new products is anticipated bringing total enrolment to over 1500 patients.
Lijckle van der Laan, MD, PhD, Vascular Surgeon, Department of Surgery, Amphia Hospital, The Netherlands and visiting Professor at Department of Cardiovascular Science KU Leuven in Belgium, enrolled the first patient in Europe and commented: “The PANTHER study is an exciting opportunity to gather long-term follow-up data on surgical grafts used to treat a wide range of cardiothoracic and vascular pathologies. I’m not aware of this type of data having been recorded previously in relation to the scope of this study and it will provide physicians with a far better understanding of the clinical behaviour of these surgical grafts.”
In the United States, Principal Investigator, Daniel Newton, MD, Assistant Professor of Surgery, Virginia Commonwealth University School of Medicine, Virginia, US added: “We are delighted to have enrolled the first patient in the US. We look forward to contributing to this global study and collecting data on grafts and patches implanted for open surgery. To date, the majority of studies on surgical grafts are limited to short-term follow-up and the study will be a significant step towards understanding long-term outcomes.”
Jeffrey Mifek, Global Vice President, Clinical and Medical Affairs at Terumo Aortic said: “PANTHER is a landmark study for the company and we are hoping that the insights from the data collated in the coming years will serve to provide the global surgical community with substantial information helping to shape future treatment options for patients. Terumo Aortic is committed to building clinical evidence that supports the entire aortic solutions portfolio.”