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Clinical trial shows made in India novel stent is safe for patients

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The data from the six-month clinical trial on the world’s first thin strut fully dissolvable stent, which was developed in India, to be safe — underscoring the Indian device industry’s ability to innovate, create and support high quality research.

“This is a big day for India and the ‘Make in India’ programme.  It also reveals to the world that our Indian device industry has the ability to be innovative, creative and support high quality research,” said Ashok Seth, Chairman Fortis Escorts Heart Institute, who was the principal investigator of the study, while presenting the findings at the prestigious Cardiovascular Therapeutics (TCT) 2016 — the biggest and best regarded meeting of interventional cardiologists in the world.

The study, titled MeRes-1, is the first-in-man study of the novel thin-strut PLLA-based sirolimus-eluting bioresorbable vascular stent (MeRes100). The researchers considered six-Month clinical, angiographic, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) results in patients with coronary artery disease.

“The innovative design of the MeRes100 scaffold developed in India addresses some of the limitations of currently available Bio-Resorbable Stents (dissolvable stents) and may have higher success and lower complication rates in the long term,” Seth said.

It would also cost much lesser than the currently available dissolvable stents and therefore give more benefit to higher number of patients, according to the study lead author.

“The MeRes-1, first-in-man study demonstrates that this new generation thinner strut sirolimus eluting BRS is both safe and effective at six months. These encouraging results provide the basis for further studies using wider range of length and sizes in more complex and larger patient population,” he added.

The stent is a unique hybrid design featuring open cells at the centre and closed cells at the edges resulting in improved track-ability and access to side branches. It also has enhanced visibility with three circumferential radio opaque markers at each end.

“Bioresorbable stents (dissolvable stents) have the potential to be greatly impactful in the treatment of coronary artery disease, and it is exciting to see these first report investigations of several new and novel stents advancing the technology forward,” said Ajay Kirtane, MD, SM, and a Co-Director of TCT.

“These results give us the first insights into their safety and efficacy, but larger randomized trials are necessary in order to establish their role in clinical practice,” he added.

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