Biotronik Inc announced that the U.S. Food and Drug Administration (FDA) has approved the commercial release of the Protos DR and VR pacemakers with Closed Loop Stimulation (CLS) technology.

This approval continues Biotronik's commitment to providing state-of-the-art solutions that enhance patients' quality of life. This product release marks a milestone for the cardiac rhythm management industry since closed-loop cardiac regulation, which has been pursued for years as an ideal approach to pacing, has never been fully realized until now.

By integrating its exclusive CLS technology into full-featured, single- and dual-chamber pacemakers, Biotronik is setting a new standard for rate-adaptive devices. Protos is the only product available on the market to translate signals sent from the autonomic nervous system to the heart to determine rate response. Traditionally, rate-adaptive pacemakers sense that patients are in motion or that they have changed their respiration rate in order to increase or decrease heart rates. Protos with CLS measures contraction dynamics in the right ventricle, thereby integrating the heart rate back into the cardiovascular control loop. In such cases, rate adaptation is accomplished by interpreting what the autonomic nervous system really needs in situations involving exercise and other demands, and then adjusts automatically to avert any possible over-response or under-response. This automaticity allows for long-term reliability and optimization, regardless of changes in a patient's heart condition.

In addition to exercise, a healthy heart responds to many factors, including emotional stress, illness, and the body's natural rhythms. Multiple international studies have suggested that CLS supports not only physical exertion, but all the other demands of daily life, thus exceeding the therapeutic features of other rate-adaptive pacemakers.

The Protos pacemaker with CLS does not require special leads to function properly. In fact, any market-released, IS-1 standard lead may be used. Therefore, current pacemaker patients requiring a replacement are eligible to receive this device.

Protos also includes all the features and functions of Biotronik's previous pacemakers, such as sophisticated diagnostics, flexible programmability, and arrhythmia detection and storage. This device is positioned to win wide acceptance for its physiologic advancement over other rate-adaptive pacemakers while remaining easy to use and program.