St. Paul, Minn.-based St. Jude said it won CE Mark approval in the European Union for its Invisible Trial app-based wireless neuromodulation system, the company said. The system leverages Apple (NSDQ:AAPL) iOS devices, specifically an iPod touch for the patient and an iPad mini for the treating physician.
The Invisible Trial system uses an external pulse generator for power, which uses Bluetooth to communicate between the iOS device controllers and the stimulator, allowing the system to be worn under clothing and controlled externally, St. Jude said. The system is able to deliver both traditional and burst stimulation modes, which have been shown to reduce paresthesia in patients.
“I expect that the St. Jude Medical Invisible Trial System will significantly improve the trial experience for my patients. The new system will be discreet, familiar and require no cables that can be uncomfortable or potentially cause the lead to dislodge. Perhaps the most important feature is the therapy itself, which will enable a unique burst stimulation mode that will expand the range of stimulation modes available in the trial phase and thereby potentially improve the trial success rate for my patients suffering from chronic pain,” Dr. Stefan Schu of Duisburg, Germany’s Sana Clinic said in a prepared statement.
“We’ve developed our new patient-centric Invisible Trial System as a response to physician and patient feedback. The system was designed to improve the comfort and usability of our system for patients evaluating spinal cord stimulation therapy to alleviate their chronic pain without focusing on potential barriers such as programming trial cables and systems with complex trial controls,” St. Jude group president Dr. Eric Fain said in a press release.
Marlborough, Mass.-based Boston Scientific said today that it is launching its Precision Novi SCS system, which has CE Mark approval for the treatment of chronic pain, in Europe. The announcement was made at the International Neuromodulation Society in Montreal.
The Precision Novi system is the smallest high-capacity primary cell SCS device currently available, the company said. Primary cell stimulators are non-rechargeable and normally larger than other SCS devices, but the Precision Novi uses the smallest high-capacity battery on the market and a wireless remote to reduce size and improve functionality, Boston Scientific said.
“The small size and novel shape of the Precision Novi implant improves patient comfort and enables a very discreet subcutaneous placement. The simplicity of the programming software saves valuable time in the operating theatre, efficiently allowing me to achieve and maintain comfortable therapy for my patients,” Dr. Simon Thomson of the UK’s Basildon and Thurrock University Hospitals said in a prepared statement.
Boston Scientific’s system uses 3-dimensional lead locations as well, said the company, and can deliver a “variety of field shapes and waveforms with or without paresthesia, including burst and higher rate frequencies.”
“We are excited to expand upon our range of therapeutic solutions for patients suffering from chronic pain. The Precision Novi System brings the power of our Illumina 3D Algorithm to the more than sixty percent of SCS patients in Europe who are treated with primary cell therapy,” Boston Scientific neuromodulation president Maulik Nanavaty said in a press release.