Navigation Links
Minneapolis Heart Institute Foundation welcomes Europace publication of Optim lead insulation paper

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

"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
Minneapolis Heart Institute Foundation

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:
(Date:12/1/2015)... ... 2015 , ... Speech and physical therapies are traditionally conducted ... and under the right circumstances, these practices can be merged. This combination ... his or her therapeutic sessions, as well as gives the physical and speech ...
(Date:12/1/2015)... ... December 01, 2015 , ... It’s official: Tattoo taboo is a ... number even greater among Millennials (a whopping one in three aged 18 to 25 ... who are dissatisfied with their ink. In fact, RealSelf , the world’s largest ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... everything. That is why Hollister Incorporated has launched the VaPro Plus Pocket™ touch ... product in the VaPro touch free catheter portfolio,” said Michael Gresavage, Vice President ...
(Date:12/1/2015)... Burlington, MA (PRWEB) , ... December 01, 2015 , ... ... the release of Clarity, the latest addition to the devices for sale in the ... technologies, 755 nm Alexandrite and long-pulsed 1064 nm Nd:YAG lasers, into a single platform ...
(Date:12/1/2015)... ... December 01, 2015 , ... With FCPX Overlay: Grit , ... control over customization, the possibilities are truly endless, all with a click of a ... position, vertical flip, horizontal flip, depth of field and more, all within Final Cut ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... Dec. 1, 2015 Building on its ... & Johnson (NYSE: JNJ ) today announced ... Companies to significantly reduce the burden of HIV ... 74 percent of new HIV infections among adolescents ... AIDS Day, these new initiatives include collaborations with ...
(Date:12/1/2015)... 2015 ) ... Equipment and Disposables Market by product, by Animal ... their offering. --> ) has ... and Disposables Market by product, by Animal - ... offering. --> Research and Markets ( ...
(Date:12/1/2015)... CytRx Corporation (NASDAQ: CYTR ), a ... announced that it has reached its enrollment target of ... clinical trial of aldoxorubicin in patients with previously treated ... completed in Q1 2016. The Phase 3 trial is a ... Assessment from the FDA at 79 sites in ...
Breaking Medicine Technology: