Navigation Links
AGA Medical Corporation Receives Approval for the AMPLATZER Muscular Ventricular Septal Defect Occluder
Date:9/10/2007

MINNEAPOLIS, Sept. 10 /PRNewswire/ -- AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) approval to market the AMPLATZER Muscular Ventricular Septal (VSD) Occluder.

The AMPLATZER Muscular VSD Occluder is intended in patients for transcatheter closure of a complex ventricular septal defect of a sufficient size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure). The patient must also be considered at high risk for surgical closure based either on the anatomy of the defect or the patient's overall medical condition. VSDs typically occur in infants and are the most common type of congenital heart defect.

"We are pleased to make the Muscular VSD Occluder available for our U.S. physician customers," said Franck Gougeon, President and CEO of AGA. "The VSD, along with the previously approved AMPLATZER Septal Occluder and AMPLATZER Duct Occluder, provide U.S. cardiologists with the most comprehensive set of tools from any single company to treat structural heart disease."

The AMPLATZER Muscular VSD Occluder consists of two discs made of self expanding nitinol. The device is implanted via a catheter, a procedure that is a less-invasive alternative to open heart surgery and results in shorter recovery time. To increase the closing ability, the discs are filled with polyester fabric that is secured to the disc. The Muscular VSD Occluder uses the unique AMPLATZER interface between the device and delivery cable. This screw attachment permits the device to be retrieved and repositioned prior to release from the cable.

As part of the approval conditions, AGA has agreed to conduct a five-year post approval study to evaluate long-term safety and effectiveness. In addition, AGA will enroll at least 100 patients in a prospective registry study that will include an evaluation of immediate post-procedural technical succe
'/>"/>

SOURCE AGA Medical Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Check if your “Favourite medical web-site” is indulging in Quackey
2. Teens turning to Internet for medical queries
3. Robots craft medical history
4. NBE to conduct test for medical students from abroad
5. Air pollution combined with greater medical needs
6. Indian Nationals with Foreign Medical Degrees can now practice in India
7. Children! Protecting them from medical mistakes
8. More information sought by patients on medical errors
9. SARS necessitates medical masks
10. Meditation Works Medically
11. Sleep Disorders Could Indicate Other Medical Problems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2015)... HealthPostures, LLC , a leading American ... it’s pioneering ergonomics products at the Wisconsin Safety and ... Professional Development Conference and Expo . The products, the ... in volume by call centers, educational organizations, retailers, government ... to a desk, the TaskMate Go 6350 and the ...
(Date:4/18/2015)... April 18, 2015 Carinsurancesavings.biz has released ... plans are cheaper during Spring. , Spring ... insurance plan. Drivers should make sure they compare the ... vehicles. Clients can learn more about Spring car insurance ... , Auto insurance quotes are becoming more and more ...
(Date:4/18/2015)... April 18, 2015 Insuranceautoquote.info has released ... online auto insurance quotes . , Clients can ... single website. The online environment provides important advantages for ... , Drivers who do not have coverage for ... during any season, day or hour. Many agencies offer ...
(Date:4/18/2015)... 2015 In the past few weeks, ... changes. , "We had to run maintenance on our ... said Jennifer Ramirez, the PR Director. "It disrupted our ... that we are back on track after having completed ... of changing phone systems which has not allowed some ...
(Date:4/18/2015)... 2015 PHOENIX, ARIZONA – In March, ... 11 other secure destruction professionals across the United States, ... He will now display “CSDS” as a professional title ... the National Association of Information Destruction 2015 Annual Conference ... Texas. Of the 20 people who took the exam, ...
Breaking Medicine News(10 mins):Health News:HealthPostures' TaskMate Products to be Exhibited at the Wisconsin and Iowa-Illinois Safety Conferences 2Health News:Auto Insurance Plans Are Cheaper During Spring! 2Health News:Clients Can Review Car Insurance Quotes Online To Find Low Cost Offers! 2Health News:TheBeautyPlace.com Temporary Number Available 2
... 50 Percent have Missing Teeth and Few Understand the ... vs. Other Physical FeaturesSAN DIEGO, Feb. 26 ... the largest known consumer survey in dentistry at the ... of Osseointegration . The survey, which evaluated the responses ...
... and CINCINNATI, Feb. 26, 2009 Reliance,Products LP and ... that the U.S.,Environmental Protection Agency (EPA) has approved new ... removal of arsenic, the parasites,Cryptosporidium and Giardia, and cause-marketing ... ) , The EPA has ...
... Pharmaceuticals (Nasdaq: ENDP ) announced today the ... of directors. Mr. Montague, 62, who was chief ... retired in July last year. Mark IV is ... for the transportation, industrial and automotive markets. He joined ...
... stress, more peace after sessions, study finds , , THURSDAY, ... emotional health of breast cancer patients, contends a new ... and distress that many women with breast cancer experience, ... in the midst of breast cancer is a significant ...
... WORTH, Texas, Feb. 26 Coria Laboratories,the newly ... VRX ), today announced six data presentations ... the American Academy of Dermatology (AAD),taking place March ... San Francisco. The,presentations demonstrate the efficacy and ...
... Calif., Feb. 26 If you,re looking for an ... Relief Program, consider Wells Fargo Bank, which has received ... Francisco-based bank has inexplicably withheld tens of thousands of ... a Southern California behavioral healthcare treatment center have used ...
Cached Medicine News:Health News:Nobel Biocare Unveils Results of the Largest U.S. Consumer Dental Survey 2Health News:Nobel Biocare Unveils Results of the Largest U.S. Consumer Dental Survey 3Health News:Nobel Biocare Unveils Results of the Largest U.S. Consumer Dental Survey 4Health News:Reliance Products and Procter & Gamble Announce EPA Approval of New Claims for PUR Purifier of Water 2Health News:Reliance Products and Procter & Gamble Announce EPA Approval of New Claims for PUR Purifier of Water 3Health News:Endo Pharmaceuticals Appoints William Montague to Board of Directors 2Health News:Endo Pharmaceuticals Appoints William Montague to Board of Directors 3Health News:Yoga May Bring Calm to Breast Cancer Treatment 2Health News:Coria Laboratories Announces Acanya(TM) Gel Data Presentations at 67th American Academy of Dermatology Annual Meeting 2Health News:Coria Laboratories Announces Acanya(TM) Gel Data Presentations at 67th American Academy of Dermatology Annual Meeting 3Health News:Coria Laboratories Announces Acanya(TM) Gel Data Presentations at 67th American Academy of Dermatology Annual Meeting 4Health News:Coria Laboratories Announces Acanya(TM) Gel Data Presentations at 67th American Academy of Dermatology Annual Meeting 5Health News:According to A Better Tomorrow Wells Fargo's Credit Card Processing Division is Withholding Tens of Thousands of Dollars Owed to a Southern California-Based Behavioral Healthcare Treatment Center 2Health News:According to A Better Tomorrow Wells Fargo's Credit Card Processing Division is Withholding Tens of Thousands of Dollars Owed to a Southern California-Based Behavioral Healthcare Treatment Center 3
(Date:4/17/2015)...  Regulatory leaders in the pharmaceutical industry continue to ... "21 st Century Cures." This ... by Congress soon and if enacted into law, it ... developed and marketed in the United States ... to consider how the proposed changes could impact their ...
(Date:4/17/2015)... -- Nonin Medical, a global leader in noninvasive medical ... Steve Bucholz will retire May 1. Company ... as Chief Executive Officer. In addition, Mr. Isaacson will ... will transition to David Noel , Chief Financial ... instrumental to Nonin Medical,s growth," Mr. Isaacson said. "Under ...
(Date:4/17/2015)... , Apr. 17, 2015 Research and Markets ... of the "Medical Equipment Rental and Leasing - ... This report analyzes the worldwide markets for ... report provides separate comprehensive analytics for the US, ... and Rest of World. Annual estimates and ...
Breaking Medicine Technology:21st Century Cures: A Regulatory Game-Changer for the Pharmaceutical Industry 2Nonin Medical's Philip Isaacson Expands CEO Role; President and COO Steve Bucholz to Retire May 1 2Medical Equipment Rental and Leasing Market 2015-2020 - Global Strategic Business Report - Healthcare Spending Slowdown Bodes Well for Medical Equipment Leasing 2
... (Amex: SYI ) today announced findings from ... can,determine a person,s haptoglobin pheno/genotype in less than ... risk in patients with,diabetes. The study was presented ... Symposium in Bethesda, Maryland., "This study shows ...
... Texas, Sept. 10 The first-ever human,clinical trial ... was,recently conducted, testing whether the tea can possibly ... trial also generated the first human safety data ... consumption of rooibos tea is safe for the ...
Cached Medicine Technology:Data Confirm Synvista Therapeutics Haptoglobin Diagnostic Test Kit Success in Rapidly Determining Cardiovascular Risk in Patients with Diabetes 2Data Confirm Synvista Therapeutics Haptoglobin Diagnostic Test Kit Success in Rapidly Determining Cardiovascular Risk in Patients with Diabetes 3Data Confirm Synvista Therapeutics Haptoglobin Diagnostic Test Kit Success in Rapidly Determining Cardiovascular Risk in Patients with Diabetes 4Clinical Trial Shows Cardiovascular Benefits of Rooibos, Popular Antioxidant Herbal Tea from South Africa 2Clinical Trial Shows Cardiovascular Benefits of Rooibos, Popular Antioxidant Herbal Tea from South Africa 3Clinical Trial Shows Cardiovascular Benefits of Rooibos, Popular Antioxidant Herbal Tea from South Africa 4Clinical Trial Shows Cardiovascular Benefits of Rooibos, Popular Antioxidant Herbal Tea from South Africa 5
... Inovise Medicals AUDICOR is the ... medical professionals worldwide quickly rule-in cardiac ... coronary syndrome, and other high-risk cardiac ... the existing workflow, AUDICOR products enable ...
... a new screening, diagnostic, treatment assessment and ... of sleep-related breathing disorders. The Watch-PAT 100 ... for an ambulatory, reliable, patient friendly diagnostic ... great number of OSA sufferers, and to ...
... C-peptide of insulin is the C-terminal cleavage ... prohormone to the mature insulin molecule. Although ... it does undergo significant liver or extra-renal ... circulating half-life than insulin [1]. In addition, ...
... (17-Hydroxy-4-androstene-3-one), a C19 steroid, is one of ... In postpubertal males, testosterone is secreted primarily ... amount derived from peripheral conversion of androstenedione ... estimated that over 50% of serum testosterone ...
Medicine Products: