St. Jude Medical’s Proclaim Elite debuts in Europe

St. Jude Medical (NYSE:STJ) said today that it’s launching its Proclaim Elite spinal cord stimulation device in the European Union after winning CE Mark approval there, including an indication for conditional MR labeling for the Proclaim Elite for head and extremity scans.

The approval also covers St. Jude’s “burst stimulation” technology, which is designed to reduce the sensation of tingling along the spinal cord associated with tonic stimulation called paresthesia, according to the Little Canada, Minn.-based company.

The Proclaim Elite device can also be fine-tuned via Bluetooth by doctors using Apple’s (NSDQ:AAPL)mobile devices, which can also be used as the patient’s controller, St. Jude said.

Earlier this month, St. Jude won FDA approval for the Proclaim Elite, claiming it as the sole U.S.-approved upgradable and recharge-free SCS system. The company is running an investigational device exemption trial in the U.S., using its Prodigy device. St. Jude said it expects to present results from the trial at the North American Neuromodulation Society’s annual meeting in Las Vegas next month.

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” neuromodulation medical director Dr. Allen Burton said in prepared remarks. “With the launch of this device we are transforming the standard of care by packaging a series of important benefits into a single SCS device. The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”

“With the Proclaim system, we’re seeing a shift in the SCS treatment paradigm as we move to a device that’s capable of delivering effective therapy tailored to a patient’s pain condition but that requires no device recharging,” added Dr. Frank Huygen of Holland’s Erasmus MC Hospital. “By combining burst stimulation and upgradeability in a non-rechargeable device, this innovative technology ensures physicians are more empowered to deliver therapy that can appropriately address our patients pain while keeping them on the forefront of therapy advancements as they are approved and securing access to MRI head and extremity scans if needed.”

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