VasQ device moves to the fore(arm)

TEL AVIV, Israel—Laminate Medical Technologies, a privately-held start-up developing VasQ, an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for hemodialysis, has announced today the first forearm fistula cases in Germany. The first surgeries were performed at six hospitals, by seven surgeons.

“As one of the worldwide first users of the VasQ external scaffold for AV anastomosis for forearm fistula creation, I am very excited about the device and the possible short, middle and long-term benefits it may provide to patients. Its application is very easy and its handling adds very little time to the fistula procedure. Since it is well established that the geometrical configuration of the AV-anastomosis is crucial for reducing the future risk of perianastomotic stenosis, in my personal opinion it would be particularly advantageous to apply the VasQ device in patients with significant distance between the radial artery and forearm cephalic vein, and therefore avoid the related unnecessary and sometimes inevitable kinking of the perianastomotic vein and associated stenosis. With excitement I am awaiting the first results of the forearm VasQ device,” said Dr. Robert Shaverdyan, head of the Vascular Access Center, Asklepios Clinic Barmbek in Hamburg, Germany.

“For me as a Vascular Access surgeon, keeping things simple is the key. Using the VasQ Forearm device is as simple as the upper arm procedure, with the same smooth and familiar handling. Therefore I am excited to see the great results of the upper arm confirmed in forearm access patients,” added Dr. Christos Petridis, MD, FEBVS, FICS, head of the Division of Vascular Surgery at Marienkrankenhaus Hamburg, Germany.

Developed by Laminate, VasQ is intended for patients suffering from kidney failure and in need of dialysis, which requires vascular access. The most common and preferred method of vascular access is an arteriovenous fistula, created by surgically connecting an artery to a vein, usually in the region of the wrist or the elbow. This allows for increased blood flow to pass through the vein, which is necessary for successful dialysis. Following a successful creation of an arteriovenous fistula, two needles are inserted through the vein to remove the patient’s blood for filtration by the dialysis machine, and then to return it.

Unfortunately, narrowing and blockage of the vein occur in more than half of newly created fistulae in response to increased pressure and thickening of the vein wall, making the fistula unusable for dialysis. As a result, the patient must undergo repeated interventions to salvage the fistula or, in cases where the fistula cannot be salvaged, use less common vascular access alternatives, affecting the ability to receive dialysis and creating a burden on hospital resources.

“Studies over several decades have consistently demonstrated that native mature fistulas have superior longevity, spanning 4 to 5 years, and require minimal secondary interventions compared with other access types. However, despite the clear benefits of mature fistulas, early failure occurs in over 40% of fistulas,” notes Laminate’s website. “Failure is often due to clotting and thrombosis of the fistula which is caused by turbulent flow patterns around the anastomosis region. Later failures are associated with exposure of the vein to high pressure and wall tension. These arterial pressures cause a thickening of the intimal layer, called intimal hyperplasia, subsequently leading to a narrowing (stenosis) of the vessel lumen. Dember et. al., 2008 report a failure rate of 53.4% at 120-150 days after fistula placement.”

VasQ is an external scaffold placed over the fistula, creating an optimal geometric configuration with the artery and reducing the tension in the vein. This allows proper blood flow during dialysis while reducing vein blockage created by thickening of the vein wall. Studies show VasQ has significant success. VasQ is a CE Marked device already in use in hospitals in Europe and in Israel, with impressive results.

“The launch of our forearm devices is encouraging news for both patients and physicians. These devices will enable patients to be implanted with VasQ in more distal fistulas, which are the first choice according to international guidelines. With over 50 hospitals already using the technology routinely with compelling results, we are excited to introduce the forearm devices which provide additional options and benefits,” said Tammy Gilon, Laminate’s CEO.