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. Close Relatives Early Death May Raise Your Heart Risk: Study
3. Newer Psoriasis Drugs May Lower Heart Attack Risk for Patients
4. New heart attack definition to be launched at ESC Congress 2012 topics: Myocardial disease
5. Your Blood Type May Boost Your Heart Risk, Study Finds
6. A vaccine for heart disease? La Jolla Institute discovery points up this possibility
7. Strategy May Help ER Docs Spot Heart Attacks Within an Hour
8. Statins Heart Benefits Outweigh Diabetes Risk: Study
9. Mechanical Device Helps Kids Waiting for Heart Transplant
10. Underinsured Heart Disease Patients Die Sooner, Study Finds
11. Some Improvement in Heart Risk Factors for Americans: CDC
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... for mental health professionals, announced today its affiliation with Tennessee Counseling Association. ... solutions to the network of the Tennessee Counseling Association, adding exclusive benefits and ...
(Date:6/26/2016)... (PRWEB) , ... June 27, 2016 , ... Quality metrics ... yet in many ways they remain in the eye of the beholder, according to ... a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified ... be personalized through a fitness app. The fitness app plans to fix the two major ... only offer a one size fits all type program , They don’t eliminate ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Bracket , ... launch its next generation clinical outcomes platform, Bracket eCOA (SM) ... held on June 26 – 30, 2016 in ... first electronic Clinical Outcome Assessment product of its kind to ... #715. Bracket eCOA 6.0 is a flexible platform ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 /PRNewswire/ ... Diabetes Tomorrow,s Leaders Scholarship is any indication, the future ... today online at www.diabetesscholars.org by the Diabetes ... stand in the way of academic and community service ... scholarship program since 2012, and continues to advocate for ...
(Date:6/23/2016)... -- Revolutionary technology includes multi-speaker listening to ... leaders in advanced audiology and hearing aid technology, has ... the world,s first internet connected hearing aid that opens ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... firsts,: , TwinLink™ - the first dual ...
Breaking Medicine Technology: