Periodic Reporting for period 2 - VENOCLOSE (World’s first absorbable percutaneous closure device for large venotomies)
Reporting period: 2021-05-01 to 2023-03-31
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 clots and cause a stroke. As the majority of VHD and AF patients are elderly, they are typically more susceptible to complications resulting from surgical procedures. Transcatheter surgical treatments of VHD and AF are currently one of the fastest developing areas in cardiology, because the procedures are significantly less invasive and easier and faster 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 punctured 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 for percutaneous VHD treatments. To provide a fully percutaneous procedure, with its allied benefits, in order to perform minimally invasive valve replacements or repairs and LAAO with minimal risk and optimal patient safety, new large hole vascular closure technology is required. 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. Consequently, 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 additional 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 is to design, develop and manufacture and Venous closure device for a First in Human study to demonstrate the clinical
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 additional 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 is to design, develop and manufacture and Venous closure device for a First in Human study to demonstrate the clinical
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 project is well advanced towards achieving its ultimate goal of developing, manufacturing, gaining regulatory approvals to roll out the PerQseal®Venous, the world’s first absorbable patch-based closure product for large venotomy closure, to the global vascular closure market. The PerQseal®Venous device has been successfully progressed through the following phases:
• Completion of Product Design and Development
• Material and Vendor selection
• IP filing in PCT and US
• Manufacturing processes and equipment designed, and fabricated
• Manufacturing line set up and commissioned
• VenoClose product produced on the manufacturing line
• Successful in vivo and in vitro device testing
• Successful completion of all Design Verification, Biocompatibility, Sterility and Validation Testing
• KOL Physician hands on use in vivo
To date, pre-clinical work with the PerQseal®Venous has demonstrated:
• Rapid deployments with effective closures in large venotomies (this will lead to a reduction of total in OR procedure times).
• Closure procedures being completed by one operator (this will facilitate a reduction in the vascular surgery team involvement).
• Effectively instant closures achieved by several KOL Cardiologists (our primary customers) who used PerQseal®Venous in pre-clinical testing. (These KOLs explained that the speed and efficacy of the closure procedure gives them confidence they will see a reduction of hospitalisation time for their patients who are treated with PerQseal®Venous and expected to see an economic benefit for the overall cost of the procedure due to the opportunity to reduce the length of stay (LOS) for patients treated in the OR and hospital).
• Completion of Product Design and Development
• Material and Vendor selection
• IP filing in PCT and US
• Manufacturing processes and equipment designed, and fabricated
• Manufacturing line set up and commissioned
• VenoClose product produced on the manufacturing line
• Successful in vivo and in vitro device testing
• Successful completion of all Design Verification, Biocompatibility, Sterility and Validation Testing
• KOL Physician hands on use in vivo
To date, pre-clinical work with the PerQseal®Venous has demonstrated:
• Rapid deployments with effective closures in large venotomies (this will lead to a reduction of total in OR procedure times).
• Closure procedures being completed by one operator (this will facilitate a reduction in the vascular surgery team involvement).
• Effectively instant closures achieved by several KOL Cardiologists (our primary customers) who used PerQseal®Venous in pre-clinical testing. (These KOLs explained that the speed and efficacy of the closure procedure gives them confidence they will see a reduction of hospitalisation time for their patients who are treated with PerQseal®Venous and expected to see an economic benefit for the overall cost of the procedure due to the opportunity to reduce the length of stay (LOS) for patients treated in the OR and hospital).
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.
In general, surgical procedures produce significant amount of waste that can be hazardous for the environment. PerQseal®Venous will reduce the need for secondary surgical treatments by reducing the risk for patient complications thanks to its PerQseal®Venous. In addition, by reducing the number of open-heart surgeries, the usage of chemicals (e.g. anaesthesia, opioid pain medication, sterilization fluids) and surgical material (e.g. bandage, swaps) will be reduced.
Vivasure supports the endeavours of the EU to pursue gender equality. As female patients are disproportionately affected by tricuspid valve disease, PerQseal®Venous can contribute directly to the health of women, offering them the best possible care.
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.
In general, surgical procedures produce significant amount of waste that can be hazardous for the environment. PerQseal®Venous will reduce the need for secondary surgical treatments by reducing the risk for patient complications thanks to its PerQseal®Venous. In addition, by reducing the number of open-heart surgeries, the usage of chemicals (e.g. anaesthesia, opioid pain medication, sterilization fluids) and surgical material (e.g. bandage, swaps) will be reduced.
Vivasure supports the endeavours of the EU to pursue gender equality. As female patients are disproportionately affected by tricuspid valve disease, PerQseal®Venous can contribute directly to the health of women, offering them the best possible care.