Vivasure Medical
Revolutionising Arteriotomy Management

Until the early 19th century, surgeons had to resort to open surgery to diagnose and treat non-palpable diseases. In 1806, Philipp Bozzini invented Lichtleiter (or Light Conductor), a primitive endoscope, marking the beginning of endoscopic procedures. And a century later, in 1910, Swedish surgeon Hans Christian Jacobaeus made further advancement by performing the first laparoscopic procedure in humans. In the ensuing years, numerous physicians refined and popularised the approach for laparoscopy to arrive at today’s modern minimally invasive surgeries (MIS). Arguably, the advent of MIS has been the most significant leap in surgical discipline towards patient safety. By allowing surgeons to perform complex operations through tiny skin incisions, MIS brings a lot of advantages, including increased accuracy, decreased risk of complications, lesser pain, and shorter recovery periods. Thus, it is no wonder patients, surgeons, and the healthcare system as a whole have been increasingly pushing for the development of more minimally invasive procedures. However, this burgeoning popularity of MIS is subsequently turning the spotlight on a few of the shortcomings in the post-surgical domain that should be addressed to make minimally invasive procedures more efficient.

Take arteriotomy management (the sealing and healing of incisions on a patient’s body), for instance. While MIS has been swiftly advancing, arteriotomy management is one area that has primarily remained underdeveloped. Currently, the two prevalent techniques for arteriotomy management involve using suture-based or collagen-based vascular closure devices. But despite their benefits in arteriotomy management, both can lead to untoward outcomes during operative procedures. The suture-based approach, on the one side, requires pre-procedural steps that can cause considerable inconvenience for patients, like blood loss and pain. It also has a high failure rate, necessitating multiple attempts or sutures to close the arteriotomy site. And on the other side, even collagen-based vascular closure devices are not fail-proof in large-bore arteriotomy management. While collagen might be good at stopping bleeding, it could lead to bruising or major vascular complications, which can even be fatal.

Interestingly, changing the script in this regard is Vivasure Medical, an innovative medical device company. Vivasure has developed a patch-based closure device—PerQseal— specifically designed to seal large-bore arteriotomies in endovascular procedures. Notably, PerQseal’s patch is made from a bioabsorbable polymer that has been used in a variety of blood-contacting applications over the years, enabling the vessel to recover to its pre-procedure state (within 180 days). Moreover, PerQseal closes the arteriotomy site from inside the vessel. The ultra-low-profile patch has an abluminal surface that promotes adherence and healing.

Considering such popularity of PerQseal within the healthcare sector, Vivasure is now gearing up to release an updated version of the solution dubbed PerQseal BLUE for venous access-site closures

PerQseal, therefore, offers surgeons a dedicated and uncomplicated solution for large-bore arteriotomy management.

Taking Large-Bore Arteriotomy Management to the Next Level

What’s driving PerQseal ahead of its competition is its simple yet secure deployment. PerQseal comes with a dedicated 0.035-inch compatible introducer that facilitates automatic loading of the implant and its intuitive delivery. The device has a safety guidewire on that front, which remains in-situ until the implant is released. And thanks to this over-the-wire (OTW) deployment by the device, it requires no pre-procedural steps.

“With more and more structural heart and aortic vascular procedures transitioning to completely percutaneous approaches, swift and secure vessel closure has become a high priority for interventional cardiologists,” states Andrew Glass, CEO of Vivasure Medical. “By getting rid of the inconvenience and vascular complications associated with arteriotomy management, PerQseal offers them a simple and reliable tool for sutureless closure in large-bore vascular procedures,” adds Glass.

PerQseal’s intuitive implant delivery combined with its unparalleled safety profile and device success rate indeed elevates the standard of patient care in minimally invasive endovascular procedures today.

Expanding the Frontier for Novel Transcatheter Endovascular Procedures

Having acquired the European conformity (CE) mark, PerQseal is extensively used in hospitals across Europe. Physicians increasingly leverage PerQseal for arteriotomy management in novel transcatheter endovascular procedures like transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR). Concurrently, the device has been consistently garnering positive reviews from patients and physicians alike, owing to its peerless capabilities. Driven by such wide acceptance, Vivasure is now set to enter the FDA pivotal trial and venture into the U.S. market, the world’s largest medical device market.

To propel Vivasure in this endeavour, the company has a pool of experts with comprehensive know-how in the cardiovascular and medical device sectors. Glass himself has vast leadership and product development experience in the medtech and cardiovascular domains to spearhead this undertaking. Similarly, one of the co-founders and also the COO of the company, Gerard Brett, has more than two decades of expertise in the medtech industry. Brett has handled various critical roles in multiple MNCs.

Chris Martin, the other co-founder and CTO, is also a wellrecognised industry expert. Their combined plethora of experience working with startups as well as MNCs in the medical device industry and the field of vessel closure become their strong differentiators.

Sealing and Healing of Abdominal Aortic Aneurysm Made Quicker

To elaborate further on how Vivasure sets a benchmark in the domain with PerQseal, Glass shares a case scenario of abdominal aortic aneurysm (AAA) patients. “Usually, the patients suffering from AAA are often prone to experience sudden rupture of aneurysms, and when that happens, it is best to treat them immediately because such ruptures can cause life-threatening bleeding,” says Glass. During those kinds of situations, surgeons generally resort to percutaneous procedures rather than open surgeries.

However, the pre-procedural preparation time for the percutaneous procedure is often too long to start the treatment instantly. But when the surgeons use PerQseal to treat such patients, they can offer faster relief to the patient with shorter sealing and healing time of the arteriotomy site. “PerQseal’s unique competencies are giving surgeons an upper hand, especially during such emergencies,” remarks Glass.

Paving the Pathway for a Safer Tomorrow

Considering such popularity of PerQseal within the healthcare sector, Vivasure is now gearing up to release an updated version of the solution dubbed PerQseal BLUE for venous access-site closures. The new version features an enhanced bioabsorbable patch designed to address more complex patient anatomies and manage the bleeding complications associated with large-bore venous access-site closures. “Venous access-site closures are a completely different ballgame than arterial access-site closures. It’s a different challenge that requires a tailored solution,” remarks Glass.

At the beginning of next year, Vivasure will enrol the first patient in its Frontier V study, a European multicenter study to evaluate the efficacy of PerQseal BLUE. It will subsequently mark a pivotal era in percutaneous cardiovascular procedures. Briefing on that, Glass points, “Our aim is to build a broad portfolio of patch-based bioabsorbable solutions for all types of closures. By exploring and catering to diverse arteriotomy applications in different minimally invasive procedures, Vivasure is going to play a prominent role in the dawning era of MIS in healthcare,” concludes Glass.