Vesalio’s NATURE Study of enVast Coronary Thrombectomy System Commences Enrollment

January 6, 2022–Vesalio recently announced enrollment commencement for the randomized, multicenter NATURE clinical study of the company’s enVast thrombectomy system for patients with ST-segment elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention.

The NATURE clinical trial will compare the safety and efficacy of the CE Mark–approved enVast system as an adjunctive measure to conventional intervention to the standard of care for patients with STEMI and large thrombus burden.

“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,” commented Professor Marco Valgimigli, MD, who enrolled the first patient in the study at Cardiocentro Ticino Istituto in Lugano, Switzerland, where he is Deputy Chief of Cardiology.

Prof. Valgimigli further explained that the goal of NATURE is to assess the comparative effectiveness of the enVAST technique versus standard of care. The results, he said, could provide a new therapeutic opportunity for those with large thrombus burden, for whom procedural success and long-term outcomes remain a challenge.

Steve Rybka, Chief Executive Officer of Vesalio, noted, “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.”