Boston Scientific Launches Pacemaker Series in Europe

The FDA currently is reviewing the devices for the U.S. market.

Boston Scientific has received CE Mark for several devices for the European market. The company is launching the Ingenio and Advantio pacemakers as well as the Invive cardiac resynchronization therapy pacemakers (CRT-Ps).

Pacemakers are designed to treat patients with bradycardia, a condition in which the heart beats too slowly—typically under 60 beats per minute. The Ingenio and Adventio pacemakers operate with RightRate, which is a Boston Scientific pacing technology for the treatment of chronotropic incompetence, which is the inability of the heart muscle to respond appropriately to physical activity, making it difficult to perform everyday activities such as climbing stairs or walking. RightRate contains a minute ventilation sensor and is programmable.

The Ingenio family of pacemakers and CRT-Ps are remotely programmable and readable, as they are expected to be compatible with Boston Scientific’s Latitude NXT remote patient management system. The company claims this will allow physicians to conduct follow-ups without the patient having to physically visit the doctor’s office. The system also should be able to sense cardiac events between checkups and transfer this information via landline or cellular-based telephone technology.

Although Ingenio and Advantio pacemakers are not yet available in the United States, they currently are under review by the U.S. Food and Drug Administration.

Boston Scientific is headquartered in Natick, Mass. The company also has offices in France where one of the first Ingenio implants was performed.

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