Vivasure Medical has treated the first patient in a clinical study investigating its large-hole synthetic closure system in patients undergoing percutaneous cardiovascular procedures.
The successful implant was completed at the Erasmus University Hospital in Rotterdam, The Netherlands.
The prospective, multi-centre, non-randomised clinical trial (NCT05951634) is evaluating the safety and performance of the PerQseal Elite. The study, called ELITE, plans to enrol up to 120 patients at 12 sites across Europe.
The device is for the treatment of large-hole venous procedures, such as transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device. Large-hole arterial access is required for these procedures, and standard treatment is via suture or collagen-based closure devices. Vivasure states that these approaches can lead to vascular complications.
Ireland-based Vivasure says its sutureless implant is fully absorbable and is placed from inside the vessel wall, making deployment easier.
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Principal investigator Professor Nicolas Van Mieghem said: “Fast and precise vessel closure is a crucial, final component of large-bore arterial access procedures. Clinicians must act quickly to mitigate the risks of unnecessary and potentially life-threatening bleeding.”
Vivasure raised €30m ($32.4m) in March 2023 via a strategic investment from US-based blood and plasma supplier Haemonetics. The investment was part of a Series D financing round, adding to €22m raised in May 2022.
Vivasure also secured an investigational device exemption from the US Food and Drug Administration (FDA) in March 2023. The company expects to complete the US pivotal study of its PerQseal system, called PATCH, by the end of this year. Vivasure plans to enrol up to 188 patients.
Vivasure estimates the large arterial closure market to be worth $300m annually.
The company already has a CE-marked device for arteriotomy closure in groin access procedures.
Vivasure CEO Andrew Glass said: “We’re looking forward to gathering data about the latest generation of the PerQseal system as we continue to innovate and add to our product pipeline.”
