Navigation Links
CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for Pericardial Closure
Date:9/10/2010

ATLANTA, Sept. 10 /PRNewswire/ -- CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation. Patients enrolled in the trial will undergo circumferential reconstruction of the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures and will be compared to subjects who do not undergo pericardial closure.

The clinical trial, anticipated to enroll more than 400 patients at up to 15 cardiac surgery sites in the United States, is being initiated by CorMatrix following analysis of data from a retrospective study that demonstrated a statistically significant reduction in the rate of new onset postoperative atrial fibrillation in CABG patients following pericardial closure with the CorMatrix ECM. Data from this retrospective study have been accepted and will soon be published in a peer-reviewed journal.

"We've heard anecdotally for some time that the use of CorMatrix ECM technology to reconstruct the native pericardial anatomy seems to reduce the risk for new onset postoperative atrial fibrillation," said Robert G. Matheny, M.D., Chief Scientific Officer, CorMatrix Cardiovascular. "Following a review of the retrospective data and the growing data on the incidence and significance of postoperative atrial fibrillation, we believe this is an important study to undertake."

Following cardiac surgery, new onset postoperative atrial fibrillation is the most common arrhythmic complication, with reported incidence between 32% and 64%, and poses a serious concern for patie
'/>"/>

SOURCE CorMatrix Cardiovascular, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. CorMatrix(R) ECM(TM) Receives CE Mark for Cardiac Tissue Repair
2. CorMatrix Announces Publication of Pre-Clinical Data in Journal of American College of Cardiology (JACC) Demonstrating the Role of CorMatrix ECM(TM) Technology in Remodeling Cardiac Tissue
3. CorMatrix(R) Announces Intramyocardial Injection of Emulsified ECM Technology(TM) Demonstrates Enhanced Angiogenesis and Improved Cardiac Function in a Preclinical Model
4. Say Goodbye to Unwanted Love Handles: CoolSculpting by ZELTIQ™ Receives FDA Clearance for Patented, Non-Invasive Cooling Treatment for Fat Reduction
5. Watsons Generic Yasmin® Receives FDA Approval
6. Shanghai SynTheAll Pharmaceuticals Co., Ltd. (STA) Receives ISO 14001 Certification
7. Celsion Receives SBIR Grant To Expand Its Technology Platform
8. Ascension Orthopedics Receives FDA Approval for TITAN™ Modular Total Shoulder System
9. K-V Pharmaceutical Company Receives Notification From New York Stock Exchange of Compliance With Quantitative Continued Listing Standards
10. Actavis Receives FDA Approval of Atomoxetine HCl Capsules
11. Abbott Receives FDA Approval for First Automated Molecular Test for Assessing Hepatitis B Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... , May 1, 2015   Heska Corporation ... the "Company"), a provider of advanced veterinary diagnostic and ... Grieve , Executive Chair, will present at the 16th Annual ... on May 13, 2015. The conference will be held May ... CA. Heska management will be available during the ...
(Date:5/1/2015)... , May 1, 2015 The Institute for ... health literacy award winners. The IHA Health Literacy Awards ... an impact on the practice of educating or empowering ... IHA gives awards in three categories: innovative programs, published ... Health Literacy Hero award. In the area ...
(Date:5/1/2015)... , May 1, 2015  Misonix, Inc. (NASDAQ: ... that designs, manufactures and markets innovative therapeutic ultrasonic ... debridement, cosmetic surgery, laparoscopic surgery and other surgical ... results for the third quarter fiscal year 2015 ... scheduled a conference call that same day, Thursday, ...
Breaking Medicine Technology:Heska to Present at the 16th Annual B. Riley & Co. Investor Conference 2Institute for Healthcare Advancement Announces 2015 Award Winners 2Misonix, Inc. To Report Third Quarter Fiscal Year 2015 Financial Results On Thursday, May 7, 2015 2
(Date:5/2/2015)... FL (PRWEB) May 02, 2015 We ... selected The Delray Recovery Center as one of the ... is known in the addiction treatment field for their ... members to innovate and to continue their educational efforts. ... positive workplace environment, never forgetting their purpose – to ...
(Date:5/2/2015)... Kare Visits LLC. launched in Chicago in response ... Kare Visits offers relief for caregivers by visiting loved ones ... According to the Caregiver Action Network, eight in ten caregivers ... a week caring for an elderly or disabled loved one. ... nurse, a caregiver is now empowered to schedule an on ...
(Date:5/2/2015)... With the success that Veatch Dental Consulting ... welcome Neida Miranda and Alex Shields to the team. With ... 41 years of combined experience working with dentists to ensure ... field for 8 years. She was certified as dental ... service, positive attitude and showing the importance of oral hygiene ...
(Date:5/1/2015)... NY (PRWEB) May 01, 2015 Pioneer ... will share the latest in their reclaimed wood products ... at the Jacob Javits Center in NYC this May. ... Boards, will bring much anticipated texture and color to ... seen an explosion of texture and color in the ...
(Date:5/1/2015)... The Workgroup for Electronic Data ... the use of health IT to create efficiencies in ... to the United States Government Accountability Office (GAO) for ... in Medicare. The report, “ Potential Uses of Electronically ... to the public on Apr. 24, 2015 and examines ...
Breaking Medicine News(10 mins):Health News:The Delray Recovery Center Named 2015 Top Workplace 2Health News:Chicagoan Seeks to Transform Industry by Launching an Innovative Elderly Care Solution 2Health News:Veatch Dental Consulting Services Welcomes New Team Members 2Health News:Intensely Textured Reclaimed Wood to be Unveiled at ICFF in NYC by Pioneer Millworks 2Health News:Intensely Textured Reclaimed Wood to be Unveiled at ICFF in NYC by Pioneer Millworks 3Health News:WEDI Contributes to Newly Released U.S. Government Accountability Office (GAO) Study on Potential Use of Electronically Readable Medicare Cards 2Health News:WEDI Contributes to Newly Released U.S. Government Accountability Office (GAO) Study on Potential Use of Electronically Readable Medicare Cards 3
... an associate professor in the department of mathematical ... Arts, has received the honor of "Excellence in ... Convocation at NJIT traditionally honors select faculty ... level of excellence over a sustained period. ...
... News) -- Older, overweight women have about the same power ... their leg strength and power was assessed relative to their ... normal weight, a new study has found. The finding ... to become disabled due to the loss of muscle mass, ...
... Even if health care is free, colorectal cancer screening rates ... of a new study suggest that may be due to ... Ph.D., a lecturer in psychology at Birkbeck, University of London, ... or they were going to die of cancer anyway, often ...
... (Boston) Surgeons from Boston Medical Center (BMC) have ... graft (CABG) surgery, aggressive glycemic control does not result ... with moderate control. The findings, which appear in this ... incidence of hypoglycemic events increased with aggressive glycemic control. ...
... the School of Science at Indiana University-Purdue University ... brain,s neural circuitry that may provide a better ... transmitted correctly in the brains of Parkinson,s disease ... clinicians correct these misfires. Work led by ...
... has selected Linda Meyer, RN, MSN, OCN, of West ... of the 2011 ASTRO Nurse Excellence Award. This award ... above and beyond the normal standards of nursing practice. ... grant, during the nurse,s welcome and orientation luncheon being ...
Cached Medicine News:Health News:Gifted mathematician honored at NJIT convocation 2Health News:Extra Pounds Linked to Weaker Legs in Older Women 2Health News:New modeling of brain's circuitry may bring better understanding of Parkinson's disease 2Health News:Allegheny General nurse to receive 2011 ASTRO Nurse Excellence Award 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: