Terumo Medical, a US-based subsidiary of Terumo Corp, has received an investigational device exemption (IDE) conditional approval from the FDA for its Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) in the US. The study will evaluate the safety and effectiveness of the Misago Self-expanding Stent System for use in the superficial femoral artery (SFA).
Terumo Medical claimed that this marks the company’s first US clinical trial for a premarket approval (PMA) device. A feature of the clinical trial is that it will enroll patients in the US and Japan.
Terumo’s trial, referred to as ‘Medical Device Collaborative Consultation and Review of Premarketing Applications’ under the larger ‘Harmonization by Doing’ (HBD) initiative, was selected as one of two projects to pilot the approach, which is intended to shorten the gap between product approvals in the two world healthcare markets.
In the US, OSPREY is a single-arm, multi-center, non-randomised prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the Misago Stent and 50 patients receiving percutaneous transluminal angioplasty (PTA).
The primary endpoints of the US study are primary stent patency rate at one year as confirmed by duplex ultrasound or angiography, freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.
The Misago Self-expanding Stent consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The stent is currently available for sale in Europe.
Juichi Takeuchi, president and CEO of Terumo Medical, said: “We are eager to move forward with the first harmonized clinical trial in the US and Japan. We are not only proud of the Misago Stent, but also of Terumo’s selection to participate in this precedent-setting international collaborative effort between regulators, industry, clinical researchers, patients, and academia.
“We look forward to initiate our first PMA clinical trial in the US and to bring innovative new interventional technology to market in improving patients’ quality of life.”
Takao Ohki, chairman and professor of department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial, said: “I believe this approach to shorten the time for new product approvals between the US and Japan is critical and exciting. This innovative movement could dramatically solve the current device lag issue between our countries.”