A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) said it has received CE mark approval of its newest devices for treating patients with potentially lethal heart arrhythmias and heart failure.
The Epic II ICD (implantable cardioverter defibrillator) and the Epic II HF CRT-D (cardiac resynchronization therapy defibrillator) feature faster device data transmission to speed patient follow-up exams and a “patient notifier” that gently vibrates to alert patients of critical changes in device function, the company said.
The first European implant of the Epic II VR was performed by Johannes Holzmeister, MD, and Firat Duru, MD, professor and director of pacing and electrophysiology at University Hospital (Zurich, Switzerland).
“Telemetry in the new Epic II ICD is noticeably faster, particularly when downloading stored electrograms,” said Duru. “The device also includes the first vibration-based patient notifier. Unlike other products on the market that use an audible notifier, the Epic II device may be particularly helpful for patients who have trouble hearing.”
St. Jude said the Epic II devices, which received FDA approval last month, include:
- Faster telemetry, designed to speed data from the ICD to the system programmer at a rate up to five times faster than previous St. Jude Medical devices.
- The industry's first non-audio alert, which vibrates to notify patients of critical changes in device performance so they can contact their clinician for follow-up care.
- SenseAbility technology, a St. Jude technology designed to protect against inappropriate ICD shocks.
- AutoIntrinsic Conduction Search, intended to promote more natural heart function and minimize ventricular pacing. Studies have shown that excessive ventricular pacing may contribute to heart failure in some patients.
- DeFT Response technology, designed to help physicians manage patients who require higher levels of defibrillation.
“The Epic II devices offer important benefits to patients and their physicians, including an innovative patient notification feature, advanced diagnostics and the ability to conduct faster follow-up exams,” said Eric Fain, MD, executive vice president of development and clinical/regulatory affairs for St. Jude's Cardiac Rhythm Management Division. “These devices, along with the recently launched Merlin Patient Care System, provide state-of-the-art technology to European physicians as they manage the complexities of heart failure.”
St. Jude also reported CE-mark approval for two new electrophysiology (EP) products – the Therapy Cool Path all-braided ablation catheter and the IBI-1400-CV Internal Cardioversion system.
The announcement was made at Cardiostim 2006, a biannual meeting of cardiac specialists that began yesterday in Nice, France.
St. Jude Medical will present results from its QuickOpt Optimization clinical study at Cardiostim's late-breaking clinical trials session on Friday, and is sponsoring several symposia during the international congress.
The Therapy Cool Path all-braided ablation catheter delivers radio frequency energy to specific cardiac tissue, creating lesions that interrupt the abnormal electrical signals that contribute to heart arrhythmias. The catheter's tip cools tissue as energy is applied, helping physicians create deeper, more effective lesions. Its all-braided shaft gives physicians more control and precision in maneuvering and placing the catheter.
The IBI-1400-CV Internal Cardioversion system helps physicians provide cardioversion (restoring a patient's normal heart rhythm) – via catheter – quickly and simply during EP procedures with lower voltage than is necessary for successful external cardioversion, St. Jude said. Physicians can flip a switch to change the catheter from a diagnostic tool to providing cardioversion.
St. Jude Medical also is demonstrating at Cardiostim several other products recently released in Europe.
A live case broadcast of an AF catheter ablation performed by physicians in Toulouse, France, using the company's NavX 3-D Mapping System will be broadcast today.
Medtronic reports product approvals
Another company active at Cardiostim is Medtronic (Minneapolis), which used the conference as a setting to report European approval and market availability of its Concerto/Virtuoso line of implantable devices, which includes the Concerto cardiac resynchronisation therapy-defibrillator (CRT-D) and Virtuoso single- and dual-chamber implantable cardioverter-defibrillators (ICDs).
These are Medtronic's first cardiac rhythm disease management devices with wireless telemetry, enabling communication remotely between the implanted device and programmers in a clinician's office and at implant, or between the device and a patient home monitor.
The Virtuoso ICDs and Concerto CRT-D help track and manage heart failure symptoms. They also will deliver a shock to terminate a dangerously abnormal heart rhythm. The Concerto CRT-D device also sends tiny electrical impulses to the heart muscle to resynchronize the contractions of the heart's lower chambers, helping the heart pump blood throughout the body more efficiently, Medtronic said.
The devices allow heart patients to automatically receive visual notification on a home monitor called the PatientLook Indicator when their device detects an alert, such as atrial fibrillation, thoracic fluid accumulation or a device performance issue.
If the PatientLook Indicator notes an alert condition, patients are instructed to call their physician with this important health status information. In addition, patients may also manually initiate a self-check to view the status of their condition, and get visual notification of their alert status.
“With the advent of wireless communication between implantable cardiac devices and programmers, as well as home monitors, we see new opportunities for more convenient and more effective implants, device management and patient care,” said Christina Unterberg-Buchwald, MD, of University Hospital Gottingen (Gottingen, Germany).
“These devices have the potential to improve patients' quality of life and the care they receive, because of the availability of the alert notifications,” added Dr. Dieter Zenker, MD, also of University Hospital Gottingen. Unterberg-Buchwald and Zenker worked together on the earlier Concerto AT trial.
The devices were approved recently by the FDA.
“We're raising the level of innovation with the introduction of wireless telemetry, combined with OptiVol Fluid Status Monitoring and the most advanced therapies and diagnostics,” said Steve Mahle, president of the Cardiac Rhythm Disease Management business at Medtronic.