Global surgical graft study launched by Terumo Aortic
The Terumo Aortic company has announced the launch of a global surgical graft study called PANTHER.
PANTHER is a retrospective and prospective, as well as a multi-arm, multicentre and post-market study of Terumo Aortic’s surgical grafts range (both knitted and woven) and its cardiovascular patches.
A recent press release states that the PANTHER study is unique in the world and a global first, representing a large-scale commitment to gathering extensive data on open surgical grafts provided by the company, as well as cardiovascular patches, across a large number of regions.
The study aims to observe how open surgical grafts perform over the long-term. Starting in Europe and North America, it will include over 30 sites. As described in the study protocol, there are five defined cohorts, with each cohort representing a different product family, and it will enrol roughly 900 patients, who will be followed for over the next 10 years, and planned future expansion of PANTHER to incorporate new products means the projection for enrolment figures will rise to over 1,500 patients.
In Europe, the first patient was enrolled at the Amphia Hospital, Breda, The Netherlands, by Lijckle van der Laan, who 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 am 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.”
The principal investigator in the USA, Daniel Newton (Virginia Commonwealth University School of Medicine, Richmond, USA), further added:
“We are delighted to have enrolled the first patient in the USA. 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.”
Terumo Aortic’s global vice president, clinical and Medical Affairs, Jeffrey Mifek, had this to say:
“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.”
© Terumo Corporation