Route 92 Medical has announced the first patient enrolment in its SUMMIT MAX clinical trial—a randomised, controlled, multicentre study to evaluate the performance of its next-generation Monopoint reperfusion system versus currently available aspiration catheter technology. The first patient was enrolled at Auckland City Hospital in Auckland, New Zealand, followed shortly by a patient at West Virginia University Medicine in Morgantown, USA.
“I am delighted to begin enrolment in the SUMMIT MAX study,” said Ben McGuinness (Auckland City Hospital, Auckland, New Zealand). “The early results from our initial experience with the Route 92 088 platform in the SUMMIT NZ study demonstrated an 80% TICI [Thrombolysis in cerebral infarction] 2b–3 first-pass reperfusion rate. It is an exciting opportunity to evaluate the possibility of improving interventional stroke treatment, and I hope the results of this trial will benefit future stroke patients.”
“We are happy to become the first US site to enrol a patient in the SUMMIT MAX clinical trial evaluating the Monopoint system,” added Ansaar Rai (West Virginia University Medicine, Morgantown, USA). “Randomised clinical trials such as these offer high levels of evidence and are critical in advancing the field of endovascular stroke therapy.”
The SUMMIT MAX study is a prospective pivotal trial and plans to enrol up to 220 patients at 30 sites across the USA and New Zealand. It will evaluate the clinical efficacy and safety of Route 92’s Monopoint system versus currently available aspiration catheter technology, and is intended to build on the recently published results of the SUMMIT NZ study. Results of the study are also intended to provide clinical evidence to support an application for US Food and Drug Administration (FDA) clearance.
“We are honoured to partner with the SUMMIT MAX investigators to begin our pivotal clinical trial and look forward to continued enrolment as the study progresses,” said Tony Chou, co-founder and CEO of Route 92. “We are confident that our Monopoint system featuring the 088 HiPoint and Tenzing catheters is a platform positioned to transform neurovascular aspiration thrombectomy for large vessel occlusions.”
Route 92’s HiPoint catheters, Tenzing catheters and Base Camp sheath system received FDA 510(k) clearance for neurovascular access in 2020 and have also received CE marking for first-line aspiration thrombectomy in the European Union.