A Medical Device Daily
In an announcement coinciding with the start of Heart Rhythm 2006, the Heart Rhythm Society's (HRS; Washington) annual meeting, Medtronic (Minneapolis) reported FDA approval of the Medtronic Concerto/Virtuoso line of implantable cardiac devices, the company's next generation of cardiac rhythm disease management products.
Market availability of the devices will begin next month.
The Concerto cardiac resynchronization therapy-defibrillator (CRT-D) and Virtuoso implantable cardioverter defibrillator (ICD) are the first implantable cardiac devices available with Medtronic's proprietary Conexus Wireless Telemetry, developed using the Medical Implant Communications Service (MICS, 402-405 MHz). The company said use of the MICS band “enables reliable communication between the implanted device and clinician programmers and patient home monitoring units.”
Medtronic said Conexus Telemetry is expected to enhance efficiencies at device implant and during in-office follow-up visits. At implant, there is no need for the programmer head to enter the sterile implant field, and in-office visits may be simplified when they're needed, as the physician can interrogate patients' devices via wireless telemetry without the need for surface electrodes.
Conexus Telemetry also is designed to enable automatic, wireless data transmission from the patient's device to a home monitor. Device data then will be transmitted to the clinician using the Medtronic CareLink Network, which the company describes as “the first Internet-based system to help physicians and patients better manage chronic cardiovascular disease treated by implantable device therapy.”
Communication between device and monitor will be initiated by physician-programmed device parameters or it can occur on pre-scheduled dates that are pre-programmed via the CareLink Network. If the system detects notable changes in the patient's condition or device status, a Medtronic CareAlert will be sent to the physician, providing the potential for treatment decisions before the condition worsens.
“Implantable device therapy is entering a new era with innovation focused on overall cardiac disease management and enhancing patient quality of life,” said Charles Haffajee, MD, director of cardiac electrophysiology, arrhythmia and pacing at Caritas St. Elizabeth's Medical Center (Boston). “This system's features, in combination with wireless distance telemetry, offer more convenient, yet equally effective, device management and patient care.”
The Virtuoso ICD 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.
Also at the HRS gathering, St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its Safire Ablation Catheter, and FDA clearance and the European CE mark for its Inquiry Optima PLUS Steerable Diagnostic Catheter.
The products are being featured for the first time at the HRS meeting.
St. Jude said the Safire catheter, featuring the new ComfortGrip handle, can be easily integrated into any existing radio frequency generators, and gives physicians improved comfort and control during electrophysiology procedures. “The catheter exceeded the performance expectation I had,” said Robert Schweikert, MD, of the Cleveland Clinic (Cleveland). “[It] did a great job reaching its position and then remaining stable once it was there.”
The Optima PLUS helps physicians map the heart's atria with a 24-electrode catheter that allows physicians to collect more diagnostic data, more quickly when used with St. Jude's newly approved EnSite System Version 6 software. Using this 3-D imaging technology, the physician will “see” the catheter's position inside the heart. Four electrodes on the 180-degree deflectable shaft display the loop and shaft planes of motion simultaneously.
Also at the HRS meeting:
ELA Medical, part of the Sorin Group (Milan, Italy), said it had received approval from the FDA to market Ovatio a new family of dual- and single-chamber implantable cardioverter defibrillators (ICDs).
At only 29cc, Ovatio DR is the world's smallest dual-chamber (DR) ICD, ELA Medical said. It also offers 34 joules of maximum output, which may prove useful for patients with high defibrillation thresholds that require more energy to terminate life-threatening arrhythmias.
Ovatio DR also incorporates two new features, AAIsafeR and PARAD+.
The AAIsafeR pacing mode limits unnecessary pacing in the right ventricle, which studies suggest may increase the risk of heart failure and atrial fibrillation, both of which can prove fatal in addition to imposing a heavy cost burden on the healthcare system. Ventricular pacing was reduced to only 0.2% when AAIsafeR mode was used in Ovatio DR patients with intact conduction.
ELA Medical said Ovatio's PARAD/PARAD+ has been shown to be an industry leader in reducing inappropriate shocks.
“With this combination, we can address patients with all types of heart block while offering the most specific algorithm for arrhythmia detection,” said Ken Ellenbogen, MD, professor of medicine and director of the Electrophysiology and Pacing Laboratory at Virginia Commonwealth University Medical Center (Richmond, Virginia).
To significantly reduce patient follow-up time, Ovatio ICDs are supported by new programming software that is 10 times faster than previous versions.