Terumo out of Tokyo, Japan has received FDA’s investigational device exemption (IDE) conditional approval to conduct a study of the firm’s MISAGO self-expanding coronary stent. Following up on the news, Terumo will run the well named Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) simultaneously in the U.S. and Japan. This is part of an effort to try to bridge the gap between approvals in US and Japan called “Harmonization by Doing” (HBD).
More from the press release:
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.
HBD is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and the U.S. toward international regulatory harmonization. The HBD initiative is a pilot project launched in December 2003 that seeks regulatory convergence between FDA and MHLW-PMDA (Japan’s regulatory bodies). The learning obtained in the “proof of concept” trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for purposes of collecting better data. In this pilot HBD approach, the products will be submitted for review and approval at the same time.
In the U.S., OSPREY is a single-arm, multi-center, non-randomized 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 U.S. 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 study will include up to 350 patients, a maximum of 250 patients in up to 30 centers in the U.S. and 100 patients in Japan. There have already been six patients enrolled in Japan, which received regulatory approval to begin the trial last year. The first U.S. enrollments are expected in June 2010.