PerQseal + for large diameter arterial closure: interview with Andrew Glass, CEO of Vivasure Medical


Vivasure Medical, a medical technology company based in Galway, Ireland, has developed the PerQseal device, a synthetic implant designed to seal punctures in large blood vessels. The implant is useful in a wide variety of transcaterial endovascular procedures, such as transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair. EVAR), and aims to significantly improve current closure approaches. punctures of large vessels.

The implant is an intravascular patch that is applied to the puncture from inside the vessel and is fully absorbable. The patch does not require sutures and aims to reduce the chances of negative problems occurring after the procedure, such as bleeding complications.

Vivasure has recently launched a new version of the device, called PerQseal +, which aims to provide a more robust solution to reduce the potential for complications and improve operator touch and feedback. The company recently announced the enrollment of the first patient in the Frontier V trial, a European multicenter study of the PerQseal + device.

Medgadget He had the opportunity to speak with Andrew Glass, CEO of Vivasure Medical, about the technology.

Conn Hastings, Medgadget: Please give us an overview of the types of percutaneous procedures in which punctures of large hole vessels are involved.

Andrew Glass, Vivasure Medical: Over the past decade, cardiovascular surgical procedures have increasingly shifted to minimally invasive approaches. Arterial access of large holes, usually through the leg, is necessary for physicians to perform these percutaneous cardiovascular procedures, including transcatheter aortic valve replacement (TAVR), repair of thoracic and abdominal endovascular aneurysms (TEVAR, and EVAR) and the use of a cardiac care device. (CAD).

Medgadget: How are large hole vascular punctures currently sealed? What are the disadvantages of these approaches?

Andrew Glass: The current approach to large-diameter arterial closure is surgical repair or the use of suture or collagen-based closure devices. Both result in major vascular complications ranging from 5 to 15%. This has been observed in many publications for TAVR, where vascular events since closure of the arteriotomy are the most common complication of the procedure. The challenge with current techniques is the impact on the integrity of the ship. Closing large vessels with current techniques is often associated with vessel distortion at the site of closure that can lead to stenosis, thrombus formation, or abrupt closure.

Medgadget: Please give us an overview of your PerQseal device and how it works.

Andrew Glass: PerQseal is the first fully absorbable synthetic suture-free implant for large-hole arterial punctures. PerQseal technology consists of an intravascular patch that seals the vessel from the inside, returning the artery to its natural state without any sutures, metal implants or collagen. For other locking devices, up to 30 steps must be implemented. We have optimized the deployment of our device in 10 total steps, reducing the amount of training required.

Medgadget: How does the system improve on other boat closing techniques?

Andrew Glass: With current closure techniques, there is a time during the procedure when the vessel is open and the doctor must close quickly to reduce unnecessary bleeding. Because our approach involves placing a seal from the inside of the ship, we believe our deployment is simpler and more controlled than conventional closure techniques. PerQseal does not require time-consuming pre-closure steps, allowing for patient comfort and a reduction in total procedure time. Unlike other closure technologies, PerQseal is a fully bioabsorbable solution that leaves nothing in the container. This has numerous potential benefits, such as new access to the boat and long-term safety for the patient.

Medgadget: How was the device conceived and how did you identify the need for a dedicated closure system for large catheters?

Andrew Glass: Although less invasive procedures have become increasingly popular over the past decade, they can sometimes be associated with bleeding complications and other challenges, so safe, fast, and efficient vessel closure is important for the results of the procedure. patient and to keep the costs associated with adverse events as low as possible. . Vivasure, working with an international group of clinicians, identified the need for an effective vascular closure device for large arterial punctures. Looking at the pressure models, it is logical that sealing inside is easier than outside. This served as the basis for our approach, and from day one we sought a fully bioabsorbable solution that was easy to implement for physicians and aimed to be safer for the patient. This resulted in our PerQseal product.

Medgadget: How does the new PerQseal + device differ from the first generation device?

Andrew Glass: The enhanced PerQseal + device is designed to provide physicians with an even more robust solution for managing the challenges and complications of bleeding associated with closing large holes. The design of the device is optimized to provide improved control and tactile feedback to the clinician, while providing the user with additional leeway to manage a wider range of vessel wall damage that can occur during catheter procedures. of large dimensions. This is particularly the case for the growing elderly population undergoing cardiovascular procedures where the arteries tend to be more calcified and less resistant, making them more susceptible to complications.

Medgadget: Give us an overview of the ongoing study of Frontier V.

Andrew Glass: The Frontier V study is a multicenter clinical trial in Europe evaluating the next-generation PerQseal + device with an enhanced bioabsorbable patch designed to address anatomies of more complex patients undergoing percutaneous cardiovascular procedures. 25 patients will join the first phase of the Frontier V study, followed by the second phase, with up to 90 patients across Germany and the Netherlands. Enrollment is expected to end this year and the resulting data will serve as the basis for our US clinical plan.

Link: Home page of Vivasure Medical …

Flashbacks: PerQseal large absorbable hole closure without suture that arrives in Europe; Perqseal Vivasure bioabsorbable large hole femoral closure device cleaned in the EU;

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