Today, Vesalio announced the start of enrollment in its NATURE study using enVast™, the company’s first thrombectomy system for patients presenting with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.
NATURE is a randomized, multi-center clinical trial comparing the safety and efficacy of enVast™ as an adjunctive measure to conventional intervention versus the standard of care in STEMI patients with large thrombus burden.
The first patient in the study was enrolled by Professor Marco Valgimigli, Deputy Chief of Cardiology at Cardiocentro Ticino Istituto, in Lugano, Switzerland.
“Our first-in-human case series of 61 STEMI patients with large thrombus burden allowed us to develop a safe and effective thrombectomy technique using the enVast™ stent retriever under continuous aspiration. With the NATURE study, our goal is to assess the comparative effectiveness of this novel technique versus the standard of care. The results could provide a new therapeutic opportunity for patients with large thrombus burden, who still represent a major challenge for procedural success and long-term outcomes,” said Dr. Valgimigli.
Coronary Artery Disease is the number one cause of death globally. Approximately 17 million patients experience myocardial infarction every year, with more than 3 million presenting with a large thrombus burden in STEMI.
“We are excited to diversify the use of our Drop Zone™ technology and venture into this critical indication, where we anticipate making a positive impact on patient outcomes as Vesalio has achieved in stroke intervention,” commented Steve Rybka, Vesalio Chief Executive Officer.
The Vesalio enVast™ coronary thrombectomy system is CE approved.
Founded in 2013, Vesalio is a privately held medical device company committed to advancing patient care in vascular occlusion by providing physicians superior technology designed to improve clinical outcomes. The company’s proprietary NeVa™ platform was designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from patient anatomy.
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