Navigation Links
Minneapolis Heart Institute Foundation welcomes Europace publication of Optim lead insulation paper
Date:8/21/2012

MINNEAPOLIS, MN August 21, 2012 The Minneapolis Heart Institute Foundation, an international leader in cardiovascular research, today announces the online publication of a study in EP Europace that raises serious concerns about St. Jude Medical defibrillator leads. The study found that a new copolymer of silicone and polyurethane (Optim) might not prevent insulation abrasions that can result in electronic malfunction. The paper is authored by Foundation researchers Robert Hauser, Raed Abdelhadi, Deepa McGriff and Linda Retel, and it is another in a series of Foundation publications that have reported significant problems with defibrillator leads, including recalled Riata and Riata ST leads from St. Jude Medical (SJM).

Defibrillators are implanted in patients to prevent sudden cardiac death.

Defibrillator leads deliver energy to the heart in order to stop abnormal, rapid heartbeats that can cause blackouts and death. These leads must be able to function properly during years of service in the body.

The paper "Failure of a Novel Silicone-Polyurethane Copolymer (Optim) to Prevent ICD Lead Insulation Abrasions" appears on the journal's web site and is available at http://europace.oxfordjournals.org/content/current.

"Our paper presents data that suggest Riata ST Optim and Durata ICD leads may not be adequately protected from insulation abrasions caused by friction with the pulse generator can or other leads in the heart," stated Dr. Hauser. "We need studies to determine the incidence of these failures and the implications for patients. At this time we do not believe that patients should be unduly concerned or their leads replaced. We do believe that patients with these leads should be evaluated regularly, as recommended by their physicians."

This study follows on the heels of a recent FDA order that St. Jude Medical launch new studies focusing on the performance of its Riata and Duranta defibrillator leads.

"We know new leads need to be implanted for years before useful reliability data can be collected," stated Dr. Hauser. "We are still in the process of gathering information about Optim, so these are not definitive data, and at this point in time we do not see a direct risk to patients."

The purpose of this study was to determine if Optim, a unique co-polymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator leads from abrasions that cause lead failure. The FDA's Manufacturers and User Device Experience (MAUDE) database search returned 15 reports for Riata ST Optim and 37 reports for Durata leads, which were submitted by SJM based on its analyses of returned leads for clinical events that occurred between December 2007 and January 2012. Eight of 15 Riata ST Optim leads had can abrasions and 3 abrasions were caused by friction with another device, most likely another lead. Twelve Durata leads had can abrasions, and six leads had abrasions caused by friction with another device. The paper concludes that Riata ST Optim and Durata ICD leads have failed due to insulation abrasions and that Optim did not prevent these abrasions, which developed up to four years after implant. The paper recommends that studies are needed to determine the incidence of these failures and their clinical implications.


'/>"/>
Contact: Steve Goodyear
sgoodyear@mhif.org
612-863-1658
Minneapolis Heart Institute Foundation
Source:Eurekalert

Related medicine news :

1. Former Vikings and NFL Greats Tackle Sleep Apnea at Upcoming Minneapolis Event
2. Minneapolis Heart Institute Foundation welcomes Europace publication of Optim™ lead insulation paper
3. Witnessing, Experiencing Traumatic Events May Worsen Heart Disease
4. Risk of suicide and fatal heart attack immediately following a cancer diagnosis
5. Cancer Diagnosis May Raise Odds for Suicide, Heart Attack Death
6. In children born with severe heart defect, surgical management has little effect on neuro outcomes
7. Invasive heart test being dramatically overused, Stanford study shows
8. Heart failure patients with diabetes may benefit from higher glucose levels
9. Omega-3 Supplements No Help Against Repeat Heart Trouble: Review
10. EKG Heart Test May Predict Risk in Older Adults
11. Common Blood Pressure Drug Safe for Heart Failure: Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2020)... ... 2020 , ... Fujirebio Diagnostics, Inc., a consolidated subsidiary of ... that Cigna has added ROMA® (Risk of Ovarian Malignancy Algorithm) to its national ... improving the health, well-being, and peace of mind of the customers they serve. ...
(Date:5/21/2020)... KENNESAW, Ga. (PRWEB) , ... May 21, 2020 , ... ... Representatives District 35, has been endorsed by Planned Parenthood Southeast Advocates (PPSEA). ... candidates who support family planning and the full range of reproductive health care. PPSEA ...
(Date:5/21/2020)... ... May 21, 2020 , ... The Rise of Mental ... been a lot of complications and adjustments, needless to say, more complications. With rising ... since the great depression it can be hard to escape and find peace. Adding ...
(Date:5/21/2020)... (PRWEB) , ... May 21, 2020 , ... JNL ... care industry announced the release of the SafeHealth screening software. This tool ... the need for additional staff or the cost of additional paperwork management. , SafeHealth ...
(Date:5/16/2020)... ... , ... On May 21, T1V will host a webinar featuring Dr. David B. Agus, one ... to CBS news, as we address COVID-19 and the impact on unified communication and collaboration. ... since March, many questions are left unanswered as we look at the future of UCC ...
Breaking Medicine News(10 mins):
(Date:5/21/2020)... (PRWEB) , ... May 21, 2020 , ... MedVet, a ... critical care veterinary hospital located at 601 Showers Dr., Mountain View, CA in June ... further expand access for pet care in the Silicon Valley and broader Santa Clara ...
(Date:5/21/2020)... ... ... Murrieta Genomics has partnered with Life Science Nation (LSN) ... a special discount rate to the Digital RESI 3-Day Global Conference being held June ... bring together startups with early-stage investors and strategic channel partners. The goal was to ...
(Date:5/21/2020)... ... May 21, 2020 , ... NeoTract, a wholly owned subsidiary ... urology, today announced that Naveen Divakaruni, D.O., Advocate Medical Group in Aurora, IL, ... Dr. Divakaruni has achieved a high level of training and experience with the ...
Breaking Medicine Technology: