Medtronic SureTune™3 Receives Health Canada Licence for Deep Brain Stimulation Therapy

Tuesday, June 6, 2017 Medico Legal News
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DUBLIN, June 6, 2017 /CNW/ - Medtronic plc (NYSE: MDT) today announced it has received a Health Canada licence for SureTune™3

software for deep brain stimulation (DBS). The latest innovations in the SureTune technology allow for more precise, efficient treatment while also improving patient management with centralized data storage for easy reference. SureTune3 provides patient-specific
visualization of lead location and simulated volume of neural activation to help physicians make decisions on how to program —or tune —their patient's DBS therapy.

Medtronic DBS therapy has Health Canada licence for diseases such as Parkinson's disease and treats symptoms such as tremors by applying mild electrical stimulation via leads or "guidewires" to precise targets in the brain. More than 10 million people worldwide are living with Parkinson's disease.1 According to Parkinson Society Southwestern Ontario, more than 100,000 people are impacted by the disease in Canada alone.2

SureTune3's advancements streamline the physician's workflow and allow StealthStation™ surgical planning information to be imported for lead placement —including Activa™ DBS leads. SureTune3 also contains a 3D deformable atlas to allow physicians to more precisely define anatomical structures, or the exact spot in the brain that must be stimulated to alleviate symptoms. The SureTune3 system is fully downloadable with the option to work over a hospital's server so clinical multidisciplinary teams can work flexibly. SureTune3 is currently not approved in the United States.

"It is a vital goal to obtain the best clinical outcomes for our patients. Software – such as SureTune3 - can accurately visualize patient-specific stimulation settings and expedite the data while treating patients with DBS," said Dr. Christopher Honey, Professor of Neurosurgery, University of British Columbia. "Further, this software can allow our hospital server to integrate all the procedure and patient data so I can provide more personalized case management with faster programming."

Medtronic DBS therapy applies mild electrical stimulation to precise targets in the brain to modulate specific symptom control. The brain targets are stimulated through lead(s) inserted into the brain and connected to an implantable neurostimulator through extensions running under the skin. A medical professional uses an external programmer to set and adjust stimulation settings. Medtronic DBS therapy is licensed in Canada for Parkinson's disease, dystonia, essential tremor and epilepsy and is the only DBS therapy that, under specific conditions, is full body MR conditional and can be left on during an MRI scan.

"As the pioneer in DBS therapy with more than 30 years of experience, Medtronic is committed to continuing to advance our technology," said Brett Wall, senior vice president and president of the Brain Therapies division, which is part of the Restorative Therapies Group at Medtronic. "The latest innovations to our SureTune technology allow for more precise, efficient treatment while also improving patient management with centralized data storage for easy reference. With more than 150,000 patients implanted worldwide, we strive to continue to improve both the physician and patient experience with our solutions."

About Medtronic DBS TherapyDBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain to reduce some of the most disabling motor symptoms associated with Parkinson's disease, including shaking, stiffness and movement difficulties. Medtronic DBS systems are the first and only approved for full-body MRI scans under specific conditions. Since 1997, more than 150,000 Medtronic DBS devices have been implanted worldwide.

DBS therapy is currently approved in many locations around the world, including the United States and Europe, for the treatment of the disabling symptoms of essential tremor and recent and longer-standing Parkinson's disease. Under a Humanitarian Device Exemption (HDE) in the United States, the therapy can also be used to treat chronic intractable primary dystonia. In Europe, Canada and Australia, DBS therapy is licensed for the treatment of refractory epilepsy. DBS therapy is also approved for the treatment of severe, treatment-resistant obsessive- compulsive disorder in the European Union and Australia, and in the United States under an HDE.

About MedtronicMedtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 

                                                1 Parkinson's Disease Foundation: "Who has Parkinson's?" Available at: http://www.pdf.org/parkinson_statistics. Accessed May 31, 2017.2 Parkinson Society Southwester Ontario: "Frequently Asked Questions" Available at https://parkinsonsociety.ca/frequently-asked-questions/. Accessed June 4, 2017.

SOURCE Medtronic Canada



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