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 pat
'/>"/>

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

Page: 1 2 3

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:7/9/2014)... selection for traits that are attractive to the opposite ... to mate, the tail of male peacocks being an ... Riverside have now found that sexual selection and "placentation" ... Describing the life histories of more than 150 species ... that species with placentas tend to have males that ...
(Date:7/9/2014)... A crucial piece of the puzzle behind nature,s ... that could help advance the development of artificial ... been provided by an international collaboration of scientists ... Laboratory (Berkeley Lab) and the SLAC National Accelerator ... Light Source (LCLS), the world,s most powerful x-ray ...
(Date:7/9/2014)... Researchers studying critically ill children with traumatic injuries ... patients are likely to develop a hospital-acquired infection. ... Hospital and published online in June in the ... larger efforts that could lead to the clinical ... to prevent or reverse immune system damage following ...
Breaking Biology News(10 mins):Biologists link sexual selection and placenta formation 2Biologists link sexual selection and placenta formation 3Biologists link sexual selection and placenta formation 4Postcards from the photosynthetic edge 2Postcards from the photosynthetic edge 3Immune function predicts infection risk among child trauma patients 2Immune function predicts infection risk among child trauma patients 3
... 19, 2009Scientists say they are forging ahead in developing ... renewable while having a minimal impact on the environment, ... A consensus is emerging that no one technology will ... novel methodologies will contribute to meeting biofuel needs, according ...
... Swiss Institute of Bioinformatics today announced the winners of the ... Award at the 7th annual [BC]2 Basel Computational Biology Conference. ... The winner of the 2009 SIB Young Bioinformatician Award is ... the past four years with the SIB in the Bioinformatics ...
... of Cordell Bank National Marine Sanctuary indicates that the ... is fair to good, but identifies several emerging threats ... as marine debris, ocean acidification and invasive species have ... said Dan Howard, sanctuary superintendent. "This report provides a ...
Cached Biology News:The SIB recognizes the next generation of bioinformaticians 2The SIB recognizes the next generation of bioinformaticians 3NOAA report finds threats to California's Cordell Bank Marine Sanctuary 2
(Date:1/14/2014)... 2014 EquitiesIQ, a leading informational research ... Alliqua is an emerging biomedical company acquiring, developing, manufacturing, ... market. , Free report download: http://equitiesiq.com/reports/alliqua/ , ... management team and Board, which launched the company’s new ...
(Date:1/14/2014)... (PRWEB) January 14, 2014 In recent ... motives and methods in product development and promotion has ... industry. This mistrust, fueled by concerns about the insidious ... by reports of spectacular fines to the world’s biggest ...
(Date:1/14/2014)... January 13, 2014 Bob Hainsey, a ... than 20 years in the industry, has joined ... Hainsey will serve as the society’s Science and Technology ... join SPIE as our Technology Strategist, further strengthening the ...
(Date:1/14/2014)... Park, NC (PRWEB) January 14, 2014 ... focusing on ultra-sensitive POC diagnostic platforms and novel disease specific ... first round of financing netting a total of $690,000. The ... equity capital in the company. This group of private investors ...
Breaking Biology Technology:EquitiesIQ Initiates Coverage of Alliqua, Inc. 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 3The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 2The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 3Photonics R&D Leader Bob Hainsey Joins SPIE Technical Staff 2BioMedomics, Inc. Closes $690K Round of Financing 2
... Yongye Biotechnology,International, Inc. (OTC Bulletin Board: YGYB) ("Yongye" ... of nutrients for plants and,animals in the People,s ... a conference call at 8:00 a.m. Eastern Time ... the quarter ended June 30, 2008., To ...
... Massachusetts, August 13, Shire Limited (LSE: SHP, NASDAQ: ... since July,3, 2008 it has acquired 81% of ... indirect subsidiary Shire Deutschland Investments GmbH (formerly Maia,Elfte ... respect of the remaining outstanding shares in Jerini., ...
... Finn, Jr.,C.P.A. ("Finn"), Assignee of the assets of Spherics, ... all pharmaceutical,intellectual property will be sold at a sealed ... pieces of intellectual property for sale is its lead,product, ... currently has,more than $2 billion in sales despite twice ...
Cached Biology Technology:Yongye Biotechnology International Announces Conference Call to Discuss Second Quarter 2008 Results 2Shire Announces Holding of 81% in Jerini AG and Publication of Offer Document 2Shire Announces Holding of 81% in Jerini AG and Publication of Offer Document 3