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Devices Cardiology

 News Release - May 13, 2009

Medtronic Launches Clinical Trial to Improve Quality of Care for Implantable Defibrillator Patients

Study Aims to Advance Reduction of Unnecessary Shocks

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced the launch of the Shock-Less clinical trial. This trial will identify ways physicians can improve the quality of care for patients through optimal application of device-based tools designed to reduce unnecessary shocks in patients with implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices. Specifically, the Shock-Less study aims to create evidence that will increase the use of programming tools that reduce unnecessary shocks including features on Medtronic devices, such as Medtronic’s exclusive Lead Integrity Alert(TM) (LIA) and Anti-Tachycardia Pacing (ATP) During Charging(TM).

“Medtronic has pioneered the advances in shock reduction technology, supported by large randomized clinical trials, in the last several years; in fact, with current Medtronic programming and technology, frequency of shocks can be reduced by more than 63 percent,” said Marshall Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “We are dedicated to supporting the use of those innovative programming tools with scientific research and education that will help physicians deliver the best possible therapy for their patients.”

While appropriate defibrillation therapy is proven to saves lives, unnecessary shocks can be reduced in several ways:

  • Using proprietary device programming for Medtronic’s Anti-Tachycardia Pacing (ATP) During Charging to deliver painless pacing pulses to safely and effectively terminate dangerous ventricular tachyarrhythmias;
  • Using Medtronic exclusives Wavelet(TM) SVT in single chamber ICDs and Medtronic’s PR Logic(R) in dual chamber ICDs to reduce shocks that may be delivered due to heart rhythms for which therapy is unnecessary (supraventricular tachycardias or non-sustained ventricular tachycardias);
  • Using the Medtronic exclusive Lead Integrity Alert, the first continuous ICD monitoring technology that alerts clinicians and makes real-time device changes to reduce the potential of inappropriate therapy that may result from fractured leads.
  • Maximizing device programming detection and therapy parameters to reduce shocks for non-sustained arrhythmias in Medtronic devices with short and consistent charge times.

“Despite the evidence, physicians are not maximizing the clinically proven programming tools to help reduce unnecessary shocks for their patients,” said Avi Fischer, M.D., principal trial investigator and assistant professor of Medicine and director of Pacemaker and Defibrillator Therapy at Mount Sinai Medical Center in New York. “Our aim is to document the differences in the way these devices are programmed and understand the barriers to using this proven therapy. We hope to better understand how outcomes and patient management can be improved through shock reduction.”

Physicians in the study will receive customized reports showing the reasons patients received shocks and analysis on how consistently their patient’s devices are programmed using the latest clinical evidence as compared to others in their region, and study-wide. Additionally, the trial is also designed to show how physicians change their device programming practices after shocks are delivered.

About Medtronic’s Shock-Less Trial

The prospective, quality improvement trial will enroll approximately 2,500 subjects at approximately 125 U.S. and Canadian medical centers. Medtronic implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) patients will be followed in the study for at least two years. Data will be gathered from device downloads as well as through Medtronic CareLink(R) Network transmissions, the industry’s largest remote monitoring network that currently allows more than 350,000 Medtronic patients worldwide to send cardiac device information automatically to more than 3,000 clinics in 20 countries.

Medtronic also will collect performance data on Medtronic’s proprietary shock reduction tool, Lead Integrity Alert(TM) (LIA); LIA is the exclusive continuous ICD monitoring technology that offers at least three days advanced warning in three out of four defibrillator patients with lead fracture. It safely and automatically increases the number of intervals required to detect VF (following detection of a lead fracture) to avoid treating lead fractures as VF.

LIA is available worldwide on Medtronic ICD and CRT-D devices. The latest LIA version for the newest portfolio of Vision 3D(TM) devices will be available in the U.S. in the coming months.

Medtronic Shock Reduction Research

Medtronic continues to provide the broadest portfolio of scientific research in the area of shock reduction, including:

  • ADVANCE III (Avoid Delivering Therapies for Non-Sustained Arrhythmias in ICD Patients III) is an ongoing trial to determine if Medtronic’s Anti-Tachycardia Pacing (ATP) During Charging and extending the time to detect and treat arrhythmias safely, can reduce the necessity for shock therapy in all ICD-indicated patients.
  • ADVANCE CRT-D (ATP Delivery for Painless ICD Therapy in CRT-D) showed that ATP for fast ventricular tachycardias is safe and effective in CRT candidates, and patients with coronary artery disease benefit more from biventricular ATP.
  • ADVANCE-D (ATP Delivery for Painless ICD Therapy) is an ongoing trial comparing different ATP therapies to optimize success of painless therapies for ventricular tachyarrhythmias in patients with ICDs.
  • COMFORT (Concept of Optimal Management of Ventricular Fibrillation or Very Fast Ventricular Tachycardia) is evaluating the efficacy and safety of ATP and low energy cardioversion for ventricular arrhythmias in patients with ICDs.
  • EMPIRIC (Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter-Defibrillators) proved that now standardized Medtronic device settings are as safe and effective as individual, physician-tailored device settings to reduce shocks.
  • ENTRUST originally demonstrated the safety and efficacy of ATP During Charging, which delivers painless ATP therapy during capacitor charging and prevents delay of shock therapy when needed.
  • PainFREE Rx and PainFREE Rx II (Pacing Fast Ventricular Tachycardia Reduces Shock Therapies) showed that three out of four shocks are eliminated using ATP, thus improving quality of life.
  • PREPARE (Proven Shock Reduction for Primary Prevention Patients) showed a 63 percent reduction in unnecessary shocks for primary prevention patients.
  • GEM DR showed that Medtronic’s PR Logic(R) dual chamber rhythm detection resulted in more accurate tachyarrhythmia therapy to help reduce inappropriate shocks.
  • RELEVANT (Registry on Left Ventricular Dysfunction and Non-ischemic Ventricular Tachyarrhythmias) showed that extending the time an ICD takes to detect and treat arrhythmias is safe and effective in reducing shocks for non-ischemic primary prevention heart failure patients.
  • WAVE (Worldwide Application of Marquis VR Enhancements) showed that the Medtronic exclusive Wavelet(TM) SVT discrimination feature in single chamber ICDs reduced inappropriate therapy by 78 percent.
  • SATISFACTION (Survey on Antitachycardia Pacing Strategy for the Termination of Fast Ventricular Tachycardia in Japanese Implantable Cardioverter-Defibrillator Population) will determine the efficacy of ATP to painlessly terminate ventricular tachycardias in Japanese ICD and CRT-D patients.

Medtronic and the University of Minnesota are hosting an educational session, “Unnecessary Shocks: What Are You Doing?,” on shock reduction during Heart Rhythm 2009, the annual congress of the Heart Rhythm Society at 7 p.m. ET Wednesday, May 13, 2009, at the Boston Marriott Copley Place in Boston. Pre-registration is required.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.


Source: Medtronic

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