Periodic Reporting for period 1 - DRAIOCHT (DRAIOCHT- A low-cost minimally invasive platform medical device for the treatment of disorders of the cardiovascular system.)
Período documentado: 2019-01-01 hasta 2019-12-31
Varicose veins are dilated, tortuous veins resulting from vein wall weakness and valve incompetence. Reflux and pooling of blood in the lower limb causes significant patient discomfort due to leg swelling, pain, eczema and subsequent skin changes leading to ulceration, in addition to cosmetic dissatisfaction. This chronic venous disease represents one of the biggest strains on the national health services of European and North American countries, and affects 35% of the adult population in Europe, with this percentage further increasing with age with 40% of women over the age of 50 suffering from some form of chronic venous disease.
Currently, varicose veins are treated by surgical removal or ablation of the vein to prevent blood flow through the vessel lumen. Surgical removal (suture ligation and vein stripping) was the traditional gold standard treatment with good long-term clinical outcomes, but due to the risk of general anaesthesia and wound complications, open surgery has been superseded by less invasive thermal or chemical (glue-based) ablation procedures over the past 20 years. However, patient safety is a growing concern with glue-based procedures due to the inherent risks of deep vein thrombosis (DVT) and pulmonary embolism (PE). Similarly, existing thermal ablation solutions are limited by the risk of nerve injury from overheating and the requirement for large amounts of tumescent anaesthesia (multiple painful subcutaneous injections to compress and thermally-isolate the vein prior to ablation.
Within the DRAIOCHT project, a new way to treat varicose veins was developed and tested. The device involved inserting a miniaturised catheter (tubing) into the vein, applying an electrical signal to the vein walls to allow it constrict and reduce in diameter, and then finally apply microwave heating to the vein call to induce safe vessel closure during the procedure. In the days and weeks post procedure, the vessels will completely seal and the varicose veins will ultimately be treated permanently. Importantly, this treatment approach requires no glue or sealing chemical, and therefore the risk of PE and DVT are avoided. Importantly, since the ablation (heating) is fast and shallow, the risk of damage to local nerves is also reduced compared to traditional RF ablation approaches.
In the course of the 12 month projects, the team have met a number of important milestones, namely:
1. Iteratively developed a number of catheter-based ablation devices. These devices were continually refined based on feedback from clinicians (vascular surgeons and interventional radiologists) and also based on bench top evaluation using ex-vivo tissue models;
2. Developed a novel electrical system to induce in-vessel vasoconstriction. This included both the stimulus system, but also the in-vessel expandable electrodes to deliver the electrical signals to the vessels;
3. An acute pre-clinical study that demonstrated the use-ability of the device, and the safety and efficacy of the prototype. The device was shown to be suitable for vein-delivery and deployment, and clearly contracted, ablated and sealed the vessel in a single procedure. No adverse events were recorded during the experiments.
To bring this technology out of the lab and into the clinical, a commercial pathway is required. Therefore, the project team have developed a detailed business plan and funding requirements document detailing the market opportunity, the competitive landscape and USP of the DRAIOCHT device, the regulatory pathway and reimbursement status. The team are now meeting with potential investors and licensees for the technology, in order to accelerate the path to market and clinic.
Currently, varicose veins are treated by surgical removal or ablation of the vein to prevent blood flow through the vessel lumen. Surgical removal (suture ligation and vein stripping) was the traditional gold standard treatment with good long-term clinical outcomes, but due to the risk of general anaesthesia and wound complications, open surgery has been superseded by less invasive thermal or chemical (glue-based) ablation procedures over the past 20 years. However, patient safety is a growing concern with glue-based procedures due to the inherent risks of deep vein thrombosis (DVT) and pulmonary embolism (PE). Similarly, existing thermal ablation solutions are limited by the risk of nerve injury from overheating and the requirement for large amounts of tumescent anaesthesia (multiple painful subcutaneous injections to compress and thermally-isolate the vein prior to ablation.
Within the DRAIOCHT project, a new way to treat varicose veins was developed and tested. The device involved inserting a miniaturised catheter (tubing) into the vein, applying an electrical signal to the vein walls to allow it constrict and reduce in diameter, and then finally apply microwave heating to the vein call to induce safe vessel closure during the procedure. In the days and weeks post procedure, the vessels will completely seal and the varicose veins will ultimately be treated permanently. Importantly, this treatment approach requires no glue or sealing chemical, and therefore the risk of PE and DVT are avoided. Importantly, since the ablation (heating) is fast and shallow, the risk of damage to local nerves is also reduced compared to traditional RF ablation approaches.
In the course of the 12 month projects, the team have met a number of important milestones, namely:
1. Iteratively developed a number of catheter-based ablation devices. These devices were continually refined based on feedback from clinicians (vascular surgeons and interventional radiologists) and also based on bench top evaluation using ex-vivo tissue models;
2. Developed a novel electrical system to induce in-vessel vasoconstriction. This included both the stimulus system, but also the in-vessel expandable electrodes to deliver the electrical signals to the vessels;
3. An acute pre-clinical study that demonstrated the use-ability of the device, and the safety and efficacy of the prototype. The device was shown to be suitable for vein-delivery and deployment, and clearly contracted, ablated and sealed the vessel in a single procedure. No adverse events were recorded during the experiments.
To bring this technology out of the lab and into the clinical, a commercial pathway is required. Therefore, the project team have developed a detailed business plan and funding requirements document detailing the market opportunity, the competitive landscape and USP of the DRAIOCHT device, the regulatory pathway and reimbursement status. The team are now meeting with potential investors and licensees for the technology, in order to accelerate the path to market and clinic.