Navigation Links
Terumo Medical Corp. reports first US implant in landmark study enrolling in US and Japan
Date:9/9/2010

Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation, today announced the first U.S. patient implant in the Occlusive/Stenotic Peripheral artery REvascularization StudY (OSPREY), which will evaluate the safety and efficacy of its MISAGO Peripheral Self-expanding Stent System for use in the superficial femoral artery (SFA). The procedure was performed at the Bradenton Cardiology Center in Bradenton, Florida.

A unique feature of the OSPREY clinical trial is that it will simultaneously enroll patients in the U.S. and Japan. Referred to as "Medical Device Collaborative Consultation and Review of Premarketing Applications" under the larger Harmonization by Doing (HBD) initiative, the OSPREY trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two significant world healthcare markets. The pilot program is a cooperative effort led by the U.S. Food & Drug Administration, the MHLW-PMDA (Japan's regulatory bodies), Terumo Corporation based in Tokyo, Japan, and Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation.

"We are pleased to be the first U.S. center to kick off this exciting international trial to evaluate the safety and efficacy of the MISAGO Stent System for treating patients with peripheral artery disease," said Srinivas Iyengar, MD, primary operator and site Principal Investigator for the OSPREY trial. "This is a unique and exciting opportunity for myself and the Bradenton Cardiology Center to be a part of the first international initiative to streamline the regulatory process to facilitate future medical device approvals between countries."

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 System 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. Japan received regulatory approval to begin the trial last year and has already started to enroll patients.

"Terumo Medical Corporation welcomes the Bradenton Cardiology Center into the OSPREY trial. We are not only grateful that our MISAGO Stent System was selected for the Harmonization By Doing program, but we feel privileged to be chosen as the first medical device company to embark in this important clinical initiative with two of the world's most preeminent regulatory bodies," said Juichi "Jim" Takeuchi, President and CEO, Terumo Medical Corporation. "We are proud of the MISAGO Stent System as our first PMA medical device and look forward to continuing to enroll patients into the OSPREY trial to bring this innovative peripheral artery disease treatment to the U.S. market."

The MISAGO Peripheral Self-expanding Stent System 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 unique design distributes the dynamic superficial femoral artery stress loads throughout the stent's struts providing not only flexibility, but also durability against bending, compression, and torsion. The MISAGO Stent System features the first rapid-exchange (RX) delivery catheter for use in the SFA.

The MISAGO Stent System is manufactured in Japan by Terumo Corporation and has been available in Europe since November 2007. To date, approximately 9000 femoral-popliteal units have been sold (7500 patients treated).


'/>"/>

Contact: Robert Murphy
rmurphy@storchmurphy.com
908-276-0777
The Storch Murphy Group
Source:Eurekalert

Related biology news :

1. Developments in nanobiotechnology at UCSB point to medical applications
2. Novartis awards 2010 Prizes for Immunology in recognition of outstanding contributions to immunology in medical research
3. Montana State University offers 6 new biomedical technologies for licensing
4. OSA launches new journal, Biomedical Optics Express
5. What the doctor prescribes: Customized medical-image databases
6. Scientists at University of Colorado Anschutz Medical Campus discover new fat cell
7. Symposium to explore broadening partnerships to spur medical advances for war injuries
8. ACP Medical Laboratory Evaluation program gains approval from CAP accreditation program
9. UCI receives prestigious federal research award to hasten medical advances
10. Biomedical scientist concerned about effects of oil spill on human health
11. CIMIT announces $3 million in medical research grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , April 28, 2016 First quarter 2016: ... up 966% compared with the first quarter of 2015 ... SEK 589.1 M (loss: 18.8) and the operating margin was 40% ... 0.32) Cash flow from operations was SEK 249.9 M ... revenue guidance is unchanged, SEK 7,000-8,500 M. The operating ...
(Date:4/15/2016)... CHICAGO , April 15, 2016  A ... companies make more accurate underwriting decisions in a ... offering timely, competitively priced and high-value life insurance ... health screenings. With Force Diagnostics, rapid ... and lifestyle data readings (blood pressure, weight, pulse, ...
(Date:3/31/2016)...   LegacyXChange, Inc. ... LegacyXChange is excited to release its first ... be launched online site for trading 100% guaranteed authentic ... also provide potential shareholders a sense of the value ... industry that is notorious for fraud. The video is ...
Breaking Biology News(10 mins):
(Date:6/23/2016)... 2016 Andrew D ... http://doi.org/10.17925/OHR.2016.12.01.22 Published recently in ... from touchONCOLOGY, Andrew D Zelenetz , discusses ... care is placing an increasing burden on healthcare ... therapies. With the patents on many biologics expiring, ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... a new line of intelligent tools designed, tuned and optimized exclusively for Okuma ... 12–17 in Chicago. The result of a collaboration among several companies with expertise ...
(Date:6/22/2016)... June 22, 2016 Research and Markets has ... report to their offering. ... 2014 from $29.3 billion in 2013. The market is expected to ... from 2015 to 2020, increasing from $50.6 billion in 2015 to ... forecasts during the forecast period (2015 to 2020) are discussed. As ...
(Date:6/22/2016)... 2016   ViaCyte, Inc. , a privately-held regenerative ... replacement therapy for the treatment of diabetes in clinical-stage ... Meeting.  ISSCR 2016, the Global Stem Cell Event, is ... in San Francisco.    ... follows:Event: , Focus Session: Tools for Basic and Applied ...
Breaking Biology Technology: