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| Biotronik's Eluna pacemaker--Courtesy of Biotronik |
Biotronik has a CE mark in hand for its new Eluna pacemakers, made with MRI-compatible technology and other advances designed to help them stand out in an already-crowded, stagnant market.
The new Eluna products include single- and dual-chamber pacemakers, plus cardiac resynchronization devices. All are made with Biotronik's ProMRI technology, which allow patients with the implants to safely undergo an MRI exam. Biotronik's main new ingredient: Eluna devices have event-triggered automatic transmissions of the heart's activity to physicians taken from directly inside the heart (known as IEGM, or an intracardiac electrogram).
Translated, that means an atrial fibrillation or other heart problem will be transmitted automatically, allowing physicians to evaluate and respond with quick treatment. The idea makes the Eluna pacers better monitoring tools that enable quick AF treatment or other interventions, which can improve the quality of care and potentially reduce healthcare costs by preventing more serious problems.
Biotronik's ProMRI tech may gain the most attention, however, considering that most pacemaker implants aren't safe for MRI use. Medtronic ($MDT) has competing devices on the market that are MRI-safe, and Boston Scientific ($BSX) and St. Jude ($STJ) are fast at work on similar products.
In January 2013, Biotronik won FDA approval to study its ProMRI technology in 245 pacemaker patients, and the company unveiled a new generation of MRI-safe ICDs in Europe last fall. Recently, the FDA allowed Biotronik to expand its ProMRI trial to implantable cardioverter-debrillators, making it the first in the U.S. to test whether a patient with an ICD can safely undergo an MRI.
- read the release