Medtronic the first to offer complete portfolio of full-body MR conditional neurostimulation systems for chronic pain in Canada

Medtronic Specify^TM SureScan^TM MRI Surgical Leads Rounds Out Exclusive Portfolio Designed for Access to Full-Body MRI^*

BRAMPTON, ON, Nov. 8, 2016 /CNW/ - Medtronic Canada, a subsidiary of Medtronic plc (NYSE:MDT), announced the Health Canada licence and the first Canadian implants of the new Specify™ SureScan™ MRI surgical leads, which are indicated for use as part of Medtronic's implanted neurostimulation systems (also known as spinal cord stimulation, or SCS) for chronic pain. In 2013, Medtronic introduced the first implantable neurostimulation systems for use in the treatment of chronic, intractable back and/or limb pain that are licenced for full-body Magnetic Resonance Imaging (MRI) scans under specified conditions. The licencing of Specify SureScan MRI surgical leads establishes Medtronic as the only company in Canada with a full portfolio of SCS systems licenced by Health Canada for full-body MRI.* This means physicians in Canada can now offer a Medtronic full-body MR Conditional SCS system best suited for their patients regardless of the type of neurostimulator (rechargeable or non-rechargeable) or lead type (percutaneous or surgical).

"The majority of patients implanted with SCS devices will need MRI studies in the future, and until now they have either undergone other more invasive examinations or had the SCS device explanted. Physicians and patients can now approach this therapy with the confidence that their ability to access future diagnostic procedures won't be lost. This innovation has raised the bar in the delivery of neuromodulation for treatment-refractory neuropathic pain" said Dr. Mohammed F. Shamji MD, PhD, FRCSC, neurosurgeon at the Krembil Neuroscience Centre at Toronto Western Hospital.

"An important development in the field of neuromodulation is the availability of MRI conditional devices. These devices allow for patients to undergo routine MRIs and continue to benefit from neuromodulation therapy - a previously unmet need for many of our patients. Our team is pleased that we can now offer this technology as a potential treatment option." said Dr. Suneil Kalia, MD, PhD, FRCSC, neurosurgeon at the Krembil Neuroscience Centre at Toronto Western Hospital.

Back pain is estimated to affect 8 out of 10 people at some point during their lives.¹ For some people, noninvasive options, such as medication and physical therapy, provide adequate relief; others may require surgery, nerve blocks, or medical devices, such as spinal cord stimulators or drug pumps. Spinal cord stimulators are medical devices implanted under the skin that send mild electrical pulses to an area near the spine. These pulses disrupt the pain signals traveling between the spinal cord and the brain, offering patients effective pain relief and improved function.²

"The use of MRI as a diagnostic tool has grown significantly. Studies show that 82 percent of patients implanted with a SCS are expected to need an MRI within five years of receiving their implant.³ Medtronic appreciates the opportunity to offer physicians the only full portfolio of SCS systems in Canada that allow patients access to full-body MRIs, facilitating optimal patient care and timely interventions," said Sandrine Moirez, senior business director of the Restorative Therapies Group at Medtronic Canada. "Medtronic remains committed to the advancement of spinal cord stimulation therapy overall and continues to drive technological advancements to ensure greater access to MRIs across many of our implanted Medtronic systems, such as pacemakers, ICDs and deep brain stimulation systems."

While the benefits of neurostimulation therapy are well documented, some individuals with an SCS system have traditionally been limited when receiving MRI scans, as the scans produce electromagnetic fields that can damage the device or cause injury to the patient. These patients have the option of undergoing computerized tomography (CT) scans, which work well for imaging bones and other hard materials, but are less effective in examining soft tissue. In some cases, people needing an MRI have had the system explanted prior to imaging.

Additional benefits of the Medtronic Spinal Cord Stimulation Therapy include:

• Technology that is proven to significantly relieve pain for the long term⁴ and help patients get back to the everyday activities they enjoy.²
• The opportunity for patients to "test drive" spinal cord stimulation with an external stimulator for a 3 to 10 day trial period during which they can assess how well the therapy relieves their pain during daily activities before committing to long-term therapy.
• RestoreSensor™ SureScan MRI systems feature Medtronic's AdaptiveStim™ technology, which adjusts stimulation automatically. Patients no longer have to use their programmer to make manual adjustments every time they change position.
• Personalization that empowers patients to manage their own pain therapy by adjusting their stimulation within pre-set limits.

About Medtronic
Medtronic Canada (www.medtronic.ca), headquartered in Brampton, Ontario is a subsidiary of Medtronic plc, which 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 is proud to employ over 1,600 people in Canada, serving physicians, hospitals and patients across the country. 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.

References
¹ Web site: https://www.nlm.nih.gov/medlineplus/backpain.html Accessed: February 10, 2016
² Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:179-188.
³ Desai MJ, Hargens LM, Breitenfeldt MD, Doth AH, Ryan MP, Gunnarsson C, Safriel Y. The rate of magnetic resonance imaging in patients with spinal cord stimulation. Spine. 2015 May 1;40(9):E531-.
⁴ Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4):762-770.
^* Under specific conditions. Refer to Instructions for Use.

SOURCE Medtronic of Canada, Ltd.

World's Smallest Pacemaker Licenced for Canadian Patients

The Medtronic Micra^™ Transcatheter Pacing System (TPS) is the First Leadless Pacemaker Licenced in Canada

Medtronic Canada, a subsidiary of Medtronic plc (NYSE:MDT), today announced it has received a Health Canada licence for the world's smallest pacemaker, the Medtronic Micra™ Transcatheter Pacing System (TPS). The Micra TPS is the first Health Canada licenced product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart - providing a safe alternative to conventional pacemakers without the need for cardiac wires (leads).

Comparable in size to a large vitamin capsule, the Micra TPS is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical "pocket" under the skin, and there are no visible signs of the device. The Micra TPS responds to patients' activity levels by automatically adjusting therapy.

Micra TPS is the first and only leadless pacing system to be licenced for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, providing patients with continued access to these advanced imaging diagnostic procedures.

The Micra design incorporates a retrieval feature to enable repositioning if needed; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS was designed with a feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction.

In November 2015, data from the Medtronic Micra TPS Global Clinical Trial, which included two Canadian centres, were published in the New England Journal of Medicine and presented during a late-breaking Special Report at the American Heart Association Scientific Sessions. These data showed the Micra TPS was successfully implanted in 99.2 percent of patients, there were no (0) dislodgements, and the system met its safety and effectiveness endpoints with wide margins at six month follow-up.

Data presented in August 2016 at the European Society of Cardiology (ESC) Congress showed that the risk for major complications with the Micra TPS remained consistently low, with 96 percent of patients experiencing no major complications through 12 months follow-up (95 percent confidence interval, 94.2 percent-97.2 percent, P<0.0001). The Micra TPS reduced the risk of major complications by nearly half (48 percent; hazard ratio = 0.52, P=0.001) compared to conventional systems and the risk was lower across all patient sub-groups, whether measured by age, sex or comorbidity (all hazard ratios < 1.0).

The overall reduction in major complications with the Micra TPS was associated with a 47 percent decrease (p=0.017) in the risk of hospitalization and 82 percent (p<0.001) reduction in risk of system revisions (meaning extraction, repositioning or replacement) compared to conventional pacing systems.

"Dating back to the development of the first external battery operated pacemaker more than 60 years ago, Medtronic has a long history of collaborating with clinicians to better understand the needs of patients, and then innovating new products to meet those needs," said Michael Blackwell, director of the CardioVascular Group at Medtronic Canada. "We are thrilled to be the first to introduce a transcatheter pacemaker to patients in Canada, and we're looking forward to working with physicians and educating implanters to extend the positive results of our global clinical trial experience to even more patients."

The Micra TPS was awarded CE Mark in April 2015 and FDA approval in April 2016. It is intended for use in patients who need a single-chamber pacemaker. The device was designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink^™ Network; remote monitoring of Micra devices is expected to be available in the near future.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers one of the broadest ranges of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.