BusinessWire India
Mumbai (Maharashtra) [India], December 22: India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE: MDT), announced the launch of the Symplicity™ Spyral renal denervation system (RDN) for treating high blood pressure. RDN is a minimally invasive therapy that targets nerves near the kidneys that can become overactive and cause high blood pressure. Medtronic recently announced the US Food and Drug Administration's (FDA) approval of the system which is a culmination of ten years of clinical research and development, and the system has approval of the Indian regulatory authorities too.
In India, nearly 1 in 4 adults have hypertension.[i] Hypertension is the single largest contributor to cardiovascular death; it dramatically increases risk of heart attack, stroke, heart failure, and kidney failure. Unfortunately, hypertension often goes undiagnosed as it frequently exhibits no symptoms. Raising awareness about hypertension is crucial since it is a detectable, preventable and treatable condition.
The Symplicity SpyralTM blood pressure procedure has demonstrated clinical efficacy in reducing high blood pressure[ii],[iii],[iv] which can lower serious health risks [v]. It is a minimally invasive procedure that targets nerves near the kidneys that can become overactive and cause elevated blood pressure. After sedation, the doctor makes a small incision and inserts a very thin tube (catheter) into the artery leading to the kidney. The doctor then uses the catheter to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.
Michael Blackwell, Vice President and Managing Director, Medtronic India said, "With the Symplicity blood pressure procedure, we aim to empower healthcare professionals and offer a comprehensive approach to managing uncontrolled hypertension that supports our patient-centered approach to care. The recently announced US FDA approval for the RDN system and an update earlier this year of the European Hypertension Society (ESH) guidelines, highlight the role of RDN as part of the hypertension care pathway. We are excited to offer this therapy to all eligible patients in India. As leaders in cardiovascular therapies, Medtronic remains committed to providing innovative solutions that improve patients' lives."
The Medtronic RDN program is backed by experience in more than 25,000 patients globally. It has also been studied in more than 4,000 patients in the presence and absence of medication, and in patients with high baseline cardiovascular risk, or with comorbidities. It has demonstrated significant and sustained reductions in blood pressure among patients with uncontrolled hypertension. Further, the procedure has been proven to be safe, with very low rates of adverse events.[vi]
Know the facts & talk to your doctor
Blood pressure is the force that circulating blood exerts against the walls of the arteries - and hypertension is when blood pressure is abnormally high. Hypertension is often called the "silent killer" because most people don't know they have it. Although there may not be any warning signs or symptoms shown, some people report early morning headaches, nosebleeds, irregular heart rhythms and buzzing in the ears. Hypertension can significantly increase the risks of heart, brain, kidney, and other diseases and is a major cause of premature death. vi If you or someone you know is experiencing high or difficult to control blood pressure, consult with your doctor to learn more about the Symplicity™ procedure.
[I] Geldsetzer P, Manne-Goehler J, Theilmann M, et al. Diabetes and hypertension in India: a nationally representative study of 1.3 million adults. JAMA Intern Med. 2018;178(3):363-372 -
renissl J, Manne-Goehler J, Jaacks LM, et al. Hypertension screening, awareness, treatment, and control in India: a nationally representative cross-sectional study among individuals aged 15 to 49 years. PLoS Med. 2019;16(5):e1002801
[ii] Kandzari DE, Bohm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. The Lancet. 2018 Jun 9;391(10137):2346-2355.
[iii] Bohm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomized, sham-controlled trial. The Lancet 2020; Published online March 29, 2020. DOI: 10.1016/S0140-6736(20)30554-7.
[iv] Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. The Lancet. 2017;390:2160-2170.
[iv] Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. The Lancet. 2016;387:957-67.
[v] Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. The Lancet. 2016;387:957-67.
[vi] Bohm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomized, sham-controlled trial. The Lancet 2020; Published online March 29, 2020. DOI: 10.1016/S0140-6736(20)30554-7.
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