Improving outcomes for people needing kidney dialysis

VasQ from Laminate Medical is a medical device used to create connections between arteries and veins, known as arteriovenous fistulas (AVFs), for patients requiring kidney dialysis. Manufactured in Israel, the novel device will be fully introduced to market towards the end of 2023 with support from NHS Supply Chain, helping to reduce infection rates, avoid repeat procedures and save the NHS money.

Improving outcomes

AVFs have a high fail rate for several reasons; they often become obstructed or clogged and they need to mature to allow the vein time to enlarge to a size where it can be used for dialysis. As a result they can require another procedure to unclog them or they have to be abandoned because they haven’t matured, requiring further corrective surgery.

The device acts as an external support, similar to scaffolding, that goes on the outside of the vein and artery, helping create an anatomically ideal angle between them. This increases the chances of the AVF being successful and improves its longer term durability so that it can be used faster after the initial surgery has taken place and for longer. Infection rates are low and overall patient outcomes are improved.

The alternative to a AVF is to have a different access point such as a central venous catheter (CVC). Whilst they have a high success rate, they are an expensive procedure and associated with a higher infection rate.

Real-world evidence

To create a compelling value proposition for the NHS, the company used Hospital Episode Statistics (HES) data. Working closely with senior vascular surgeon, Dr Nick Inston at Queen Elizabeth Hospital Birmingham, they mapped the patient pathway for AVFs created surgically in the UK. They explored how successful they were, how many catheters were used, if there were any complications, and if so how much the complications cost.

They created, a group of real patients and used existing clinical data to model what impact the device would have on this group. They calculated that the device could save the NHS £6 million per annum.

Furthermore they found the device also had the potential to reduce theatre space, staff time and bed stays that are currently being used for repeat procedures to treat avoidable complications.

With this evidence, the NHS Innovation Service needs assessors put the company in touch with NHS Supply Chain to discuss how to get the device to market.

Michaela Russell, Innovation Specialist at NHS Supply Chain, said

“This included discussions around the benefits the product could bring to the patient pathway, gaining insight on the clinical reviews and discussing compliant routes to market of this innovative product".

“Having this product available via NHS Supply Chain will aid take-up and adoption across the NHS, enabling more patients to benefit from its use".

MedTech consultant, Paul Hodge, who began working on the innovation in 2021, said: “When we presented the evidence to NHS Supply Chain with Dr Nick Inston, there was a lot of excitement about the potential for improved patient outcomes and significant budget impact. The next step was to prove the model, so we set up a number of centres to evaluate the procedure in the context of the NHS, which is where we currently are in the process.”

“This approach has leveraged the desire of industry, clinicians and NHS Supply Chain to introduce a highly promising new technology that is already CE marked and accelerate adoption and access for patients in the UK.”

Connections

As well as connecting the company with NHS Supply Chain, the NHS Innovation Service introduced VasQ to East Midlands AHSN (now Health Innovation East Midlands) and West Midlands AHSN (now Health Innovation West Midlands). The company is now in the process of a phased regional roll out in three trusts that give a good geographical spread, with future plans to scale nationally.

Paul continued: “The AHSNs have been superb in helping to join the dots in terms of helping to get the right people to speak to. From an education point of view, they put on a lot of seminars and webinars to help companies like ours and people like me to understand and deliver on what the NHS needs.”

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