Patients implanted with Abbott’s directional Infinity DBS system can now look forward to MR exams with less anxiety with a new software upgrade cleared by the FDA that provides the solution with MR-conditional labeling.

The addition of the over-the-air software upgrade makes the solution the first and only FDA-cleared MR-conditional directional DBS system on the market, enhancing safety and access for necessary MR procedures among patients with Parkinson’s disease, essential tremor and other movement disorders.

“MR-conditional labeling offers peace of mind to patients who may need a scan in the future,” Dr. Binith Cheeran, medical director of movement disorders at Abbott, told HCB News. “It allows centers that do intraoperative MR scans during DBS surgery to offer this advanced therapy to patients with Parkinson’s disease. An upgradeable platform allows us to bring enhancements like MR-conditional labeling to patients who have already had a directional Infinity DBS system.”
The potential need for future MR exams has made providers hesitant to offer patients advanced DBS therapy options for comfort and treatment, out of concern for their safety.

Transmitted through secure Bluetooth wireless technology, the upgrade equips patients implanted with existing Infinity DBS systems with full-body MR-conditional labeling, eliminating the need for surgical intervention.

Clearance for providing MR-conditional labeling is an endeavor that Abbott has worked for and secured in several of its products, including its Resynchronization Therapy Defibrillator (CRT-D) and Fortify Assura Implantable Cardioverter Defibrillator (ICD) solutions earlier this year. It also added MR-conditional labeling last September to its Ellipse ICD.

In addition, the upgrade also provides programming tools and expands field-shaping simulation options available to Infinity DBS users.

“A good analogy for this is a Tesla versus a traditional car. On a traditional car, like older DBS platforms, the car you buy is the car you live with. Abbott’s Infinity system is more like a Tesla,” said Cheeran. “You buy the car and add significant enhancements through over-the-air updates as required. Abbott’s Infinity DBS platform allows us to add therapy enhancements that can help maintain a patient’s ability to live the life they want to, for longer, in the face of progressive disease.”

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