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World’s first absorbable percutaneous closure device for large venotomies

Periodic Reporting for period 1 - VENOCLOSE (World’s first absorbable percutaneous closure device for large venotomies)

Reporting period: 2020-05-01 to 2021-04-30

The problem: In Europe alone, over 24 million patients per year are diagnosed with Valvular Heart disease (VHD) or atrial fibrillation (AF). Worldwide, the number of diagnosed patients even exceeds 100 million. VHD is characterized by damage to or a defect in one of the four heart valves: the mitral, aortic, tricuspid or pulmonary. AF is characterized by rapid and irregular beating of the atrial chambers of the heart, which can lead to the formation of blood cloths and cause a stroke. As the majority of VHD and AF patients are elderly, who are typically more susceptible to complications resulting from surgical procedures. Transcatheter surgical treatment of VHD and AF are currently one of the fastest developing areas in cardiology, because the procedures are less invasive and easier to perform compared to traditional open-heart surgery. These interventions require access to the heart via a large hole, or venotomy, in the femoral vein. After the femoral vein is cut open and the transcatheter heart valve treatment or left atrial appendage occlusion (LAAO) is performed, a large hole of at least 8mm needs to be closed. This venotomy closing procedure typically requires a vascular surgery team, additional anaesthesia or pain medication and prolonged hospital stay and comes with increased risk of surgical-site infection, thrombosis and vascular damage. This is a major limitation on percutaneous procedures that needs resolving in order to perform minimally invasive valve replacements or repairs and LAAO with minimal risk and optimal patient safety. In addition, because large venotomies are much more difficult to close by compression, clinicians often abandon the percutaneous approach and engage a vascular surgery team to provide access by surgically dissecting the groin area to expose the vessel. As venotomies get bigger it becomes more difficult to close them, leading to complications such as blood loss, haematoma, infection, and thrombosis. As a consequence, the associated health care costs (procedure plus patient after care) are high.

Our solution: Vivasure has developed PerQseal®Venous, the world’s first absorbable patch-based closure product for large venotomy closure (over 8 mm). Vivasure’s innovation, derived from its patented PerQseal® technology, is to deliver an intra-venous patch without additonal surgery, sealing the vessel from the inside while providing a matrix to support wound healing. The PerQseal®Venous product is largely based on Vivasure’s already existing and clinically-validated PerQseal®Arterial product, which is used to close arterial vessels and already in clinical use. Vivasure’s PerQseal® technology is world-wide patent protected. The PerQseal®Venous will be able to make transcatheter heart valve interventions and LAAOs simpler to perform. This will result in a significant cost reduction by:
Reduction in the vascular surgery team involvement;
Reduction of total procedure time;
Reduction of hospitalisation time;
Reduction of anaesthesia and post-operative opioid (pain medication) use.
In addition to the cost savings, PerQseal®Venous will improve patient outcomes by reducing the infection rates and other complications such as blood loss and thrombosis.
The overall objective of the project to to design, develop and manufacture and Venous closure device for a First in Human study to demonstrate the clinical feasibility of such a device.
The project commenced on 1st May 2020 during the height of the Covid-19 pandemic. Despite restrictions on access to hospitals and physicians throughout the first 12 months of the project and well as reduced access to our facilities, the company implemented a program of engagement with Physicians in both the US and EU. The objective was to obtain feedback on the unique challenges of venous anatomies and closing large hole in vein walls and to obtain feedback on our design concepts. Our design team developed an extensive range of implants concepts, developed prototypes and bench tested for acute sealing performance, ease of use and adaptability. Based on this wok together with Physician input, the design team produced a short list of preferred implant designs. Delivery devices and introducer sheaths were also designed, developed , prototyped and bench tested to interface with the preferred implant designs. Preclinical testing was conducted with preferred implant design together with prototype delivery systems. The tests has shown very good sealing of venotomies in porcine IVC implantation studies.
In conjunction with the design and development work the company has developed an IP strategy along with Market and Product specification. The company currently engaging in an Arterial US clinical study and has been able to leverage it's engagement with the US FDA to help guide the development of the Venous protocol, clinical operator and site selection, IRB interactions, CRO management and hospital contracting which will prove very helpful when we are ready to propose a venous closure device EFS study. The Company is also engaging in a EU Arterial clinical study and will be similarly be able to leveraging this experience.
The company is very confident of developing an effective large hole venous closure device, based on it's physician feedback and successful designs concepts to date. The immediate objective is to finalise an effective and fully tested implant design together with interface device and sheath design. The company will leverage it's extensive experience in product optimisation and validation and manufacturing capabilities as well as its First In Human study preparations and execution in either the US or EU to successfully bring the project to its conclusion.
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