Navigation Links
Myocor Receives Approval for Percutaneous Trial
Date:12/5/2007

MAPLE GROVE, Minn., Dec. 5 /PRNewswire/ -- Myocor, Inc. announced that the U.S. Food and Drug Administration has granted conditional approval of the Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) feasibility study. The single-arm feasibility study will evaluate the safety and feasibility of the percutaneously implanted iCoapsys(TM) system in treating patients with mitral valve insufficiency caused by left ventricular dysfunction and coronary artery disease (CAD).

"Percutaneous valve repair is a new frontier of patient care," said Dr. Wes Pedersen, interventional director, complex valve disorders, at the Minneapolis Heart Institute. "The iCoapsys system offers patients an innovative, less invasive option for treating their functional mitral regurgitation (FMR). It is very exciting to be able to participate in the VIVID feasibility study as the principal investigator at Abbott Northwestern Hospital."

The iCoapsys device and implant procedure are based on the original, surgically implanted Coapsys(R) system. The first Coapsys device is currently being evaluated in the RESTOR-MV trial. Both devices are designed to reduce functional mitral regurgitation and reshape the left ventricle to provide a more complete reshaping therapy than traditional mitral valve repair. The development of the iCoapsys system will allow Myocor to provide physicians with both surgical and percutaneous options for their patients.

Initiation of the VIVID feasibility study is another significant milestone for Myocor, a privately held company. Since 1996, Myocor has developed a substantial portfolio of intellectual property related to mitral valve and left ventricle reshaping. "We have been very disciplined in bringing these devices through the design, manufacturing and trial processes with an eye on long-term success," said Myocor CEO, Jim Hickey. "We have been fortunate to have the experience of implanting over 120 Coapsys devices worldwide, the dedication of a talented group of employees and clinicians who believe in our therapy, and the backing of a strong investor group."

About the technology:

The Coapsys(R) and iCoapsys(TM) devices are designed to deliver the only complete, less invasive reshaping therapy for functional mitral regurgitation (FMR) and left ventricular (LV) dysfunction.

About the company:

Myocor is a clinical-trial stage medical device company. Its primary focus is on developing pioneering therapies that restore heart geometry and function. By addressing both ventricular and valvular issues, Myocor's therapies offer a complete reshaping solution for the millions of people worldwide who suffer from debilitating functional mitral regurgitation.

CONTACT:

Randolph Jennings

507.664.0482 (direct)

jennings@neuger.com


'/>"/>
SOURCE Myocor, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
5. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
6. CryoCor Receives FDA Approval for Right Atrial Flutter
7. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
8. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
9. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
10. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
11. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Bracket , a leading clinical trial technology ... outcomes platform, Bracket eCOA (SM) 6.0, at the 52 ... 30, 2016 in Philadelphia , Pennsylvania.  A ... product of its kind to fully integrate with RTSM, will ... 6.0 is a flexible platform for electronic clinical outcomes assessments ...
(Date:6/23/2016)... , June 23, 2016 ... Oticon , industry leaders in advanced ... launch of Oticon Opn ™, the world,s first ... of possibilities for IoT devices.      (Photo: ... Oticon introduces a number of ,world firsts,: ...
(Date:6/23/2016)... 2016  Experian Health, the healthcare industry ... patient payment and care experience, today announced ... and services that will enhance the breadth ... These award-winning solutions will enable healthcare professionals ... in an ever-changing environment and redefine front-office ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department ... in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at ... Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events ... turn to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. ... tools for healthy coping following a traumatic event. , Trauma sufferers tend to feel ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
Breaking Medicine News(10 mins):