It was no coincidence that Medtronic (Minneapolis) waited until last week to spread the word about winning FDA approval for a new line of heart rhythm products — even though the regulatory agency actually approved the devices last month.

The scientific sessions of the Heart Rhythm Society (Washington), which drew roughly 14,000 attendees to San Francisco last week, provided an ideal stage for the company to promote its new Vision 3D portfolio — especially given the fact that Medtronic, a "diamond" sponsor of the event, enjoyed a primo spot in the Moscone Convention Center exhibit hall.

In April the FDA approved the "first wave" of devices under Medtronic's Vision 3D portfolio, which will include wireless implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy-defibrillators (CRT-Ds), pacemakers and cardiac resynchronization therapy-pacemakers (CRT-Ps). The portfolio's first ICD and CRT-D devices will be commercially available in the coming months, the company said.

"We listened to our customers, and made key enhancements to all devices in four areas that we call 'Vision 3D fundamentals': proven shock reduction, therapy efficacy, disease management and remote patient care," Tracy McNulty, a Medtronic spokeswoman, said in an e-mail responding to questions from Medical Device Daily. "Vision 3D represents the first time in ICD/CRT-D history that a manufacturer has introduced multiple levels of products; Medtronic also was the first to do this in pacing products with the introduction of Thera, Prodigy and Preva pacemakers in 1996, and most recently continuing with the Adapta portfolio in 2006."

Vision 3D has been in development for about three years, McNulty told MDD.

"With previous or competing devices, physicians may have had to make a choice between key features, but with Vision 3D, the fundamentals are standard across all devices," she said.

In addition to other Medtronic features, Vision 3D introduces automaticity with Complete Capture Management, intended to provide confidence in patients' safety by continuously and automatically adjusting to changing patient needs, according to Medtronic. Complete automaticity provides physicians flexibility during in-office device checks and may also reduce battery drain, the company said.

Previously, Capture Management was only available for one chamber of the heart (right atrium or left ventricle), McNulty said. Complete Capture Management captures three chambers of the heart — the right atrium, and right and left ventricles, she said. Additionally, it automatically provides a daily device check, enabling remote follow up when used with the Medtronic CareLink network, she said.

"For the first time, we have access to sophisticated defibrillators with complete automaticity to capture what's happening in three chambers of the heart and adjust the device's stimulation to the body's physiologic needs," said Anne Curtis, MD, chief of the division of cardiology and director of cardiovascular services at the University of South Florida (Tampa). "This also gives us insight into key trend data to help better manage the patient's condition, rather than simply inform us how the implanted device is operating."

Other Medtronic features available in the Vision 3D portfolio include:

Conexus Wireless Telemetry is available on all Vision 3D ICDs and CRT-Ds. Through Conexus, patients' device and condition data are automatically transmitted to clinicians and accessible remotely and electronically via the secure Medtronic CareLink network. More than 250,000 patients at nearly 2,400 clinics in 20 countries are followed remotely on the CareLink network, according to the company.

Medtronic's PainFREE strategy for shock reduction, including ATP (anti-tachycardia pacing) During Charging. Integrated into all Vision 3D ICDs and CRT-Ds, ATP During Charging automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while concurrently preparing to deliver a shock if needed, with no delay, according to Medtronic.

The company's Managed Ventricular Pacing mode, intended to allow doctors to reduce unnecessary pacing to the right ventricle, the heart's lower right chamber.

OptiVol Fluid Status Monitoring, a Medtronic feature that measures intrathoracic impedance in heart failure patients. Using very low electrical pulses that travel across the thoracic cavity (the chest area encompassing the heart and lungs), the system is designed to measure the level of resistance to the electrical pulses, which indicates fluid levels. Used in combination with the company's Heart Failure Management Report, OptiVol's ability to manage fluid status over time can provide physicians with important insights in conjunction with ongoing monitoring of other patient symptoms, Medtronic said, which may lead to timely clinical intervention.