Will another Durata failure report drag St. Jude down?

St. Jude Medical logo

Wall Street didn’t move much on news of another insulation-related failure in St. Jude Medical’s (NYSE:STJ) next-generation Durata defibrillator leads this week.

The case report included a detailed analysis of an incident in which a Durata lead failed due to inside-out abrasion, which some likened to the externalization issues that launched the high-profile recall of St. Jude’s older Riata leads.

"This most recent ICD lead failure suggests that the Durata lead can fail in a manner similar to the recalled Riata and Riata ST leads," Ohio electrophysiologist Dr. Edward Schloss wrote in a guest post published on CardioBrief. "All eyes will be watching to see if this is an isolated event, or represents an early sign of systemic trouble for this lead."

The study was published this week in the journal Heart Rhythm, the same journal that around this time last year was at the center of the dramatic foofaraw over a study linking the older Riata lead with 22 deaths. St. Jude disputed the findings of that study and asked that the journal retract the story, a request which was summarily rebuffed.

Dr. Schloss kept a close eye on the commotion, telling MassDevice.com at the time that it was unlike anything he’d seen in nearly 20 years of practicing medicine.

The latest Durata failure news didn’t appear to stir much attention from Wall Street, where yesterday’s 2.3% drop in STJ seemed more the result of a senior note offering than of the Durata report. STJ shares have slowly lost about 4.6% over the course of this week, but it’s unclear whether much of that has to do with the Heart Rhythm report.

The Durata lead in the case report was implanted in January 2008 and began to have issues in July 2010, Schloss wrote. The lead was ultimately removed in January 2013, at which time the researchers found internal abrasion in the insulation as well as degradation in the outer insulation.

"Analysis of the lead after removal showed several area of insulation degradation. There were areas of visible abraded internal silicon and ETFE insulation under the distal shocking coil that resulted in electrical over-sensing due to contact between the ring sensing cable and coil," Schloss wrote. "In addition, several areas of degradation of the Optim outer insulation were found at sites of lead flexion. Based on detailed failure analysis, the investigators concluded that the lead failed due to inside-out abrasion of the silicon inner core of the lead."

St. Jude’s spokespeople didn’t attempt to dispute the study in speaking with MassDevice.com today, but noted that the failure described in the case report is a known and very rare issue in the Durata leads, which feature an Optim coating that is designed to be more resistant to abrasion. The case report also depicted a case of under-the-shock-coil abrasion, different from the lead externalization reported with the Riata and Riata ST leads, Meyer said.

"St. Jude Medical proactively reports all known lead failures in our comprehensive biannual product performance report, including the very rare failure type of under-the-shock-coil abrasion identified in this case report," spokeswoman Amy Jo Meyer told us. "In our last PPR, we reported that the incidence rate of this failure mechanism in Durata leads remains very low."

The medical device maker plans to update its PPR data this May, and will include this latest Durata incident report, Meyer said. Current data supports the "excellent performance" of Durata and other Optim-insulated leads, she added.

St. Jude has been attempting to shield its Durata leads from the high-profile recall of its Riata and Riata ST leads, which were pulled from shelves after the company was forced to concede that the Riata revision rates were higher than previously reported. In December 2011 the FDA gave the recall Class I status, the highest-risk category for medical device recalls.

St. Jude has been busy ever since calming fears about the next-generation Durata leads, and some analysts have said that a Durata recall is not likely, even as a handful of negative reports created some waves on Wall Street. Others, such as the analysts at Citigroup, think a recall is more likely, if not downright probable.

Wall Street investors are keeping their eyes peeled for any sign of a problem with the Durata leads. In June 2012, a single report (later debunked) of a Durata lead failure similar to the kind that sank the Riata sent STJ shares plunging 6% in a single day.

RSS From Medical Design & Outsourcing

  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]
  • FDA seeks public input on Quality Metrics guidance
    by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation […]
  • First ‘Ear Wear’ for Active Adults Debuts with MDHearingAid FIT
    If you’ve burned out your ears with earbuds, headphones or decades of other audio abuse but aren’t ready for your grandmother’s hearing aids, not to worry! The new MDHearingAid FIT gets you back in the game with a tiny, FDA-registered, one-size-fits-most solution that doesn’t block your ear canal like old-fashioned in-the-ear hearing aids. The FIT feels […]
  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]

Leave a Reply