HRS2014: Medtronic cardiac rhythm implants fail 1st in head-to-head studies of longevity, researchers say

Medtech giant Medtronic (NYSE:MDT) fell last in an independent study comparing the longevity of rival CRT-D devices, researchers reported today during Heart Rhythm 2014, the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco.

Danish researchers looked at data from the nation’s ICD Register, spanning nearly 2,800 devices that were introduced to the market between 2007 and October 2013. The results didn’t look good for Medtronic’s cardiac resynchronization therapy implantable cardioverter defibrillators, which were most often the 1st to fail compared with CRT-Ds made by Boston Scientific (NYSE:BSX), St. Jude Medical (NYSE:STJ) and Biotronik.

"The longevity of Medtronic CRT-Ds was significantly shorter compared to other manufacturers," according to the study. "There was no statistical significant difference between the other manufacturers."

Lead author Dr. Jens Johansen noted a number of limitations in the study, not least of which was the lack of information regarding device settings that may have had an impact on longevity.

The 4-year survival rate for Boston Scientific and Biotronik devices were 95.7% and 95.8%, respectively, with St. Jude devices coming in 3rd with a 93.6% survival rate. The differences between survival rates in their devices were not statistically significant, but Medtronic’s implants came in at a rate of 81.1%, according to the study.

The findings may be important for clinicians deciding which devices to offer to patients, Johansen noted. CRT-D replacement procedures are costly and put patients at risk of infection, bleeding and damage to the implanted leads that connect the pulse generator to the heart.

Medtronic representatives cautioned that the researchers were looking at older devices, maintaining that new systems are on par with rivals.

"The comparisons shown on the poster at HRS are of Medtronic and BSX devices from two generations ago," Medtronic representatives told MassDevice.com today (emphasis theirs). "The Medtronic Viva/Evera platform, the company’s current devices on the market, have industry-leading warranties – CRT-D at 6 years, the same as BSX."

The Danish study didn’t specify device models or patient characteristics, but its findings appear to corroborate data from a University of Pittsburgh study, released late last year, that similarly found earlier failures in Medtronic devices.

The Pitt study examined CRT implantable cardioverter defibrillators implanted from the start of 2008 through the end of 2010. Researchers included data on nearly 650 patients implanted with devices from Medtronic, St. Jude and Boston Scientific, spanning a variety of models

In total, 4% of Boston Scientific devices required replacement at about 2.5 years (+/-1.6), 7% of St. Jude devices required replacement at 2.7 years (+/-1.5) and 25% of Medtronic devices required replacement at 2.8 years (+/-1.5).

The Pitt researchers included detailed data on the devices, including the type of therapy they provided to patients during their lifespan, but concluded that the most salient independent predictor of battery longevity was the name on the label.

The Pitt researchers also maintained that the devices involved in their study are still on the market and poised to impact new patients. In contrast to older studies, the Pitt study "includes only contemporary CRT-ICD models available in the USA and the rest of the world," researchers said.

Battery-wars have been a staple of the cardiac rhythm implant market for years. Last year’s Heart Rhythm conference also featured battery data from Boston Scientific, claiming its single-chamber ICDs, dual-chamber ICDs and CRT-Ds last an average of 13.2, 11.5 and 9.2 years, respectively. In May 2013 Boston Scientific publicly flogged its rivals over device longevity, calling out Medtronic’s claims that its Viva portfolio of cardiac resynchronization defibrillators, which had just recently won FDA clearance, came with an 11-year battery life.

Boston Scientific responded with an attack ad proclaiming that the Viva line only lasted 4.6 years in clinical tests, stating "Medtronic just launched their new high-voltage platform. We just have one question… Why another sub 5-year CRT-D?"

Medtronic called the ad "frankly misleading," countering with a "Reality Check" that claimed Medtronic’s ICDs lasted longer in "7 independent studies, including over 10,600 patients at 15 centers."

Boston Scientific has something of a reputation for its CRM battery life, having won European Union and FDA approval to market several of its implants as featuring longevity of up to 10 years. In 2012 group purchasing organization Novation highlighted the company’s efforts to boost battery life as a must for all implantable device makers.