Medtronic of Canada Ltd.

Medtronic of Canada Ltd.

April 17, 2012 10:30 ET

Medtronic of Canada Receives Health Canada Licence for Interventional Procedure for Treatment-Resistant High Blood Pressure

The Medtronic Symplicity Renal Denervation System: the First Licenced Medical Device in Canada for Treatment-Resistant Hypertension

BRAMPTON, ONTARIO--(Marketwire - April 17, 2012) -

ATTN: National Healthcare Editors -

Medtronic of Canada Ltd. (Medtronic), a trusted Canadian leader in innovative medical technologies and health system solutions, today announced that it has received a Health Canada licence for the Medtronic SYMPLICITY RENAL DENERVATION SYSTEM™ to reduce treatment-resistant high blood pressure in patients unresponsive to three or more anti-hypertensive medications. Hypertension is a life-threatening disease affecting over 5 million Canadians, with 4.5% experiencing resistant hypertension; uncontrolled blood pressure despite receiving optimal anti-hypertensive therapy(i).

"Decreasing a patient's systolic blood pressure from 160 to 130 mm Hg over a period of six months, which renal denervation has been shown to do, could prevent many heart attacks and strokes from ever happening," said Dr. Barry Rubin, Medical Director at the Peter Munk Cardiac Centre in Toronto, Ontario. "Our multidisciplinary renal denervation program, which includes interventional radiologists, vascular surgeons, cardiologists, hypertension and kidney specialists will treat many eligible patients in the months ahead."

The Symplicity Renal Denervation System™ accomplishes renal denervation via a minimally invasive procedure that disables sympathetic nerves located in the renal artery walls, which has been shown to reduce high blood pressure. The system consists of a generator and a flexible catheter. The catheter is introduced through the femoral artery in the upper thigh and is threaded up into the renal artery near each kidney. Once in place, the tip of the catheter delivers low-power radio-frequency (RF) energy according to a proprietary algorithm, or pattern, to ablate the surrounding sympathetic nerves. The procedure does not involve a permanent implant.

Clinical research to date shows that renal denervation with the Symplicity Renal Denervation System™ may provide a significant and sustained reduction in blood pressure levels for many patients with treatment-resistant blood pressure despite taking multiple anti-hypertensive medications. Results from the SYMPLICITY HTN-1 trial have shown sustained safety and effectiveness of renal denervation with the Symplicity Renal Denervation System out to three years, and results from the SYMPLICITY HTN-2 trial showed safe, and statistically significant reduction of blood pressure (-33 mg Hg systolic blood pressure) at six months following the procedure and sustained to 12 months. These data were recently presented at the annual American College of Cardiology during an oral session, which was dedicated to renal denervation.

Medtronic is leading the development of renal denervation. In addition to the licence from Health Canada, the Simplicity Renal Denervation System™ has received Europe's CE (Conformité Européene) mark and a listing with Australia's Therapeutic Goods Administration (TGA). The Symplicity Renal Denervation System is under investigational use in the United States.

About the SYMPLICITY HTN-1 and HTN-2 Trials

SYMPLICITY HTN-1 is a series of pilot studies involving 153 patients at 19 centers in Australia, Europe and the United States. Subjects in the SYMPLICITY HTN-1 trial maintained an average blood pressure reduction of -33/-19 mm Hg at 36 months (n=24) from baseline (p <0.001) following treatment with the Symplicity renal denervation system. An increasing proportion of patients who completed follow-up had at least a 10 mm Hg reduction in systolic blood pressure. At 6 months 71 percent of patients were classified as responders, which increased to 100 percent among the patients who completed three year follow-up. There was no evidence of renal impairment, no patients were hospitalized due to hypotension, and no procedure-related serious adverse events were seen.

The SYMPLICITY HTN-2 trial is an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with treatment-resistant hypertension. One hundred-six (106) patients were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centers. At baseline the randomized treatment and control patients had similar high blood pressures: 178/97 mm Hg and 178/98 mm Hg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. The analysis included data from 47 patients initially treated, who at 12 month follow-up sustained their significant drop in blood pressure (-28/-10 mm Hg [p <0.001] from baseline) with no significant difference from the previously reported 6 month follow-up (-32/-12 mm Hg [p=0.16]). In addition, 35 qualified patients in the control group who received renal denervation 6 month post randomization also showed a similar drop in blood pressure to the treatment arm at 6 months post procedure (-24/-8 mm Hg [p= 0.15] from 6 month treatment arm). Safety results were sustained with no significant decline in kidney function and no late vascular complications.

About Hypertension

Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. Hypertension is estimated to have a direct cost to the global healthcare system of more than $500 billion annually. Although pharmaceutical therapy plays a primary role in hypertension management, drugs alone are sometimes not effective for all patients. As a result, despite lifestyle changes and the availability of anti-hypertensive agents, approximately 50 percent of patients with hypertension remain uncontrolled, and approximately 15-20 percent of those are resistant.(ii)

About Medtronic of Canada Ltd.

Medtronic of Canada Ltd. is a trusted Canadian leader delivering innovative health system solutions and advanced medical technologies to alleviate pain, restore health, and extend life in the areas of cardiovascular medicine, diabetes, spinal and neurosurgery, and ear, nose, throat surgery. Medtronic is proud to employ more than 745 Canadians. Headquartered in Brampton, Ontario, Medtronic has regional offices in Vancouver and Montreal, including a manufacturing facility, Medtronic CryoCath, located in Pointe-Claire, Quebec.

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


(ii) Circulation. ( 2010 Feb 23;121(7):e46-e215. Epub 2009 Dec 17. Heart disease and stroke statistics 2010 update: a report from the American Heart Association.

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