Business Wire India
India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE:MDT) — a global leader in healthcare technology, today announced the launch of CE marked fourth-generation flow diverter, PipelineTM Vantage with Shield TechnologyTM for endovascular treatment of brain aneurysms. Pipeline™ Vantage with Shield Technology™ is a new flow diverter with enhanced design features to both the delivery system and implant. These features allow physicians to deliver, deploy and treat brain aneurysms, intracranial aneurysms with greater ease and reliability while providing a scaffold that promotes growth of cells in the inner lining of the target blood vessel.
Cerebral or brain aneurysm is a condition where there is a ballooning or weakening of the inside wall of an artery in brain. As a result of weakening, the artery bulges out and can burst or rupture due to the pressure of the blood flow. Rupture of an aneurysm causes profuse internal bleeding, strokes, and even death. Aneurysm flow diversion is a minimally invasive treatment in which a device known as a neurovascular stent placed in the parent blood vessel of a brain aneurysm may divert blood flow away from the aneurysm. Over time, blood flow into the aneurysm may slow down, eventually ceasing to enter the aneurysm altogether. As the body’s natural healing process works with the flow diversion device, the blood vessel may heal, and the aneurysm may shrink.1-4.
Every year in India, around 76,000 to 200,000 cases of aneurysmal subarachnoid hemorrhage (SAH) are reported to have occurred. Since brain aneurysms are most prevalent between 35 and 60 years of age and about 40% of the ruptures are fatal, a great number of disability adjusted life years are lost.5 Advances in flow diversion over the last 10 years has helped to significantly reduce the rate of aneurysm rupture.6
“Since 2013, we’ve been disrupting aneurysm treatment, advancing the practice and raising the standard of care in India. Medtronic is consistently committed to bringing innovative technologies to India to improve quality of life for patients and ease of doing procedure for surgeons. Our newest PipelineTM Vantage Embolization Device comes with a one-of-its-kind warranty for device efficacy. With this, we hope to boost patient assurance on our offerings while encouraging flow diversion as a form of therapy for aneurysms,” said Rahul Arora, Director of Neurosciences Therapies, Medtronic India.
With the commitment to advance access to healthcare in India, Medtronic is also introducing a first-of-its-kind warranty program called the PED Warranty Program. Through the warranty program, patients treated with Medtronic’s Pipeline Embolization Device (Pipeline™ Flex Embolization Device with Shield Technology™/ Pipeline™ Vantage with Shield Technology™) will receive a warranty coverage.
Flow diversion therapy has lesser chances of reestablishment of blood flow into the occluded aneurysm than other modalities with comparable acute morbidity and mortality rates.7 The Pipeline™ embolization device is the most studied flow diverter worldwide with a proven safety and efficacy profile. 8,9 Medtronic’s fourth-generation PED Pipeline™ Vantage Embolization Device with Shield Technology™ has been designed keeping in mind the strong clinical evidence for flow diverters as a mode of treatment for aneurysms.
1 Pipeline™ Flex Embolization Device IFU
2Becske, T. et al. Long-term clinical and Angiographic outcomes following Pipeline Embolization Device treatment of complex internal carotid artery aneurysms: Five-year results of the Pipeline for uncoilable or failed aneurysms trial. www.neurosurgery-online.com(opens new window). Volume 80. January 2017.
3 Szikora I, Marosfoi M, Salomváry B, Berentei Z, Gubucz I. Resolution of mass effect and compression symptoms following endoluminal flow diversion for the treatment of intracranial aneurysms. AJNR Am J Neuroradiol 2013;34:935-9.
4 PREMIER Clinical Study Report Medtronic FD3563 Rev B. 12-SEP-2018
6. Al-Mufti, F., Amuluru, K., Gandhi, C. D., & Prestigiacomo, C. J. (2016). Flow Diversion for Intracranial Aneurysm Management: A New Standard of Care. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 13(3), 582–589. doi:10.1007/s13311-016-0436-4
7. ISAT: International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping vs endovascular coiling
8. PMA- P100018-S011
9. Scientific Communication Document search (2018) showing clinical summaries. No other studies meet these criteria
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