St. Jude Medical ($STJ) announced a duo of FDA approvals today, driving the company's share price up 2%. The agency gave the go-ahead to St. Jude's MultiPoint Pacing technology for the enhancement of the company's cardiac resynchronization therapy devices as well as the Axium Neurostimulator System for the treatment of chronic intractable pain of the lower limbs.
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| Quadra Allure MP--Courtesy of St. Jude Medical |
St. Jude hopes the MultiPoint Pacing technology will reduce the non-response rates of the Quadra Assura MP and Quadra Allure MP CRT devices. The technology will deploy newly approved quadripolar pacing Quartet LV leads. It will be made available to physicians in the first half of the year.
"MultiPoint Pacing technology allows physicians the opportunity to capture more left ventricular tissue quickly by delivering pacing pulses to multiple left ventricle locations rather than the traditional single pulse for each heartbeat. Using the Quartet LV lead with its four uniquely spaced electrodes, physicians now have the capability to program two pulses from a single lead and tailor them to the specific needs of each patient," St. Jude said in a release.
The PMA supplement approval for modifications to previously approved high-risk devices also includes a programmer-based test to enable the optimal therapy options to be programed for individual patients.
"Having the ability to truly individualize cardiac resynchronization therapy is a significant step forward in the clinical approach to treating some of our most complex heart failure patients," said Dr. Gery Tomassoni, director of electrophysiology at Baptist Health in Lexington, KY, in a statement. "MultiPoint Pacing technology provides a new set of tools that can be non-invasively programmed in an attempt to improve CRT response, thus opening up an important new treatment option for many patients who may need it."
More than 23 million people across the world have congestive heart failure, the company says, with 2 million additional cases diagnosed each year.
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| Axium Neurostimulator System--Courtesy of St. Jude Medical |
Meanwhile, the Axium Neurostimulator System was approved to stimulate the spine's dorsal root ganglion in a bid to "give physicians the ability to treat the specific areas of the body where pain occurs." It's for patients who are underserved by traditional spinal cord stimulation who have tried multiple treatment options without receiving adequate pain relief, according to a release.
"The approval of St. Jude Medical's DRG neurostimulation system represents an exciting new option for me to deploy in the fight against the focal and intractable chronic pain syndromes facing my patients every day," said Dr.
The device was approved via the stringent PMA pathway for high-risk devices. Patients in the pivotal trial were randomized to the Axium or a competitor's approved traditional tonic spinal cord stimulation device. Axium patients experienced superior pain relief at three and 12 months, St. Jude said in the release.
Axium earned European CE mark approval in 2011. St. Jude invested $40 million in product developer Spinal Modulation in 2013, and in May 2015 exercised its $300 million option to acquire the Menlo Park, CA, company. St. Jude must pay the former company's owners revenue-based milestones following U.S. commercialization.
St. Jude's 2015 Neuromodulation sales rose 9% at constant currencies to $475 million. But annual sales of cardiac rhythm management devices fell 3% at constant currencies to $2.5 billion as the company lost market share due to a lack of MRI compatible devices.
- read the release about the MultiPoint Pacing technology
- read the release about the Axium