Forging an entirely new category of vein care options, Sapheon brings its new VenaSeal System to the market with commercial operations in Europe and future plans to launch domestically in the US. The company is planning to commence an IDE-randomized US clinical study this year.
Not yet approved by the FDA , VenaSeal, the next new thing in vein care, uses a different type of technology than traditional thermal ablative modalities. The VenaSeal System uses an adhesive technology; it’s the next generation and the next giant step.
Since its CE Mark approval in Europe, VenaSeal is currently sold in Germany, the Netherlands, Denmark, UK, Austria, Norway, Switzerland, and Italy. The technology has
recently been introduced into Hong Kong and this year will be looking to move into Canada.
VEIN sat down with Dr. Rod Raabe, inventor and cofounder of Sapheon, and Prof. Thomas Proebstle, an internationally-based dermatologist and phlebologist, to discuss what’s on the horizon for the US vein world as the number of patients treated with the VenaSeal Sapheon Closure System continues to expand.
Innovation – Inspiration
Dr. Rod Raabe, an interventional radiologist who has practiced in the US for nearly 30 years, has always had a passion for medical innovation. “Through my involvement with the Society of Interventional Radiology (SIR ), I helped start a program called Legs for Life—a screening program to detect and study lower extremity arterial disease. It was during this time, I invented a sheath for the delivery of stents and balloons.”
“The idea to close the veins with an adhesive came to me when we were doing an embolization of an arterial vascular malformation in the brain. We were using a cyanoacrylate glue and I was thinking, ‘If we could glue a high risk, high flow vascular lesion in the brain, why couldn’t we glue shut a vein that is low flow?’ ” recalls Raabe. “Little did I know it would take more than 2 ½ years of chemical engineering to come up with the appropriate properties that would work in the veins. The glue needed to adhere very tightly and rapidly without embolizing and still have elastic properties.” Developed at the same time was a transvenous catheter system to deliver the adhesive. “We developed an innercatheter with properties that could not accidently be glued into the vein and is very visible under ultrasound to allow for the precise delivery of adhesive every time.”
VM: Okay, if you’re filling up the veins and they are very big, that’s a lot of glue!
RR: Actually, the average amount of glue we use for an entire greater saphenous vein (GSV) is less than a thimbleful— about 1.2 ccs. We aren’t using the glue as a filler. Instead, it coapts the vein circumferentially with compression.
VM: What is needed, as far as the technical skills are concerned, for a physician to get the hang of the VenaSeal System?
RR: The delivery of the adhesive uses a very similar technique to ablative therapies, as it is catheter directed and uses ultrasound for guidance.
The catheter is attached to a unique delivery system, which administers the exact amount of adhesive required at each point along the vein. Once you find the position near the saphenofemeral junction with ultrasound, you simply pull the trigger while holding compression. This injects the adhesive, which causes the vein to be circumferentially glued together. In only three minutes the glue polymerizes, creating a very tight adhesive bond.
What is unique to VenaSeal are the steps we are not using—which are the most painful steps for the patient. We use no tumescent anesthesia so the only thing the patient feels is the initial small needle stick. In all of our clinical studies to date, none of the patients treated with VenaSeal were required to wear compression stockings.
VM: Tell us about the adhesive you’re using. Is this something that has been used previously?
RR: The active ingredient in the adhesive is cyanoacrylate— the same thing used in dermal glues which have been used in medicine for more than 50 years and have not shown any significant adverse effects in those applications. So we really have more than 50 years of experience with this active ingredient.
Normal cyanoacrylates are very hard and brittle once they cure. We had to specially design this glue so it would polymerize faster, would not embolize, and would stay exactly where it is put. We also designed it to stay soft and flexible for a long period of time so that patients cannot feel it post-treatment.
Most other cyanoacrylate glues have to be mixed at the time of the procedure. Our adhesive comes premixed and it is a simple process.
Physician, Heal Thyself— Or Have a Friend Do It...
VM: So after all these years of vein work, you’ve finally crossed over to the other side of the exam table to get the VenaSeal procedure done yourself. What made you finally pull the trigger?
RR: As a physician wearing a heavy lead apron over my clothes for most of my career, standing on my feet, and extensive travel, I ended up with “cankles” and my legs felt heavy and uncomfortable. In my left leg I was a CEA P 4A , and on my right leg I was a CEA P 3; it was getting to a point where I was starting to get permanent venous changes in one of my legs, so I said, “Enough is enough.”
Once VenaSeal was approved with a CE Mark, the principle investigator, Prof. Thomas Proebstle, said, “Why don’t I fix this when you come to Germany next time.” He treated both legs in about a half hour, and all I needed after the treatment was a Band-Aid. I could actually feel the relief immediately when I stepped off the table because I didn’t have any tumescent anesthesia or compression stockings. Ten minutes after the procedure, we walked down the street to an Italian restaurant. The next day, I drove the German Autobahn south through Switzerland and Italy and then hiked the trails in Cinque Terre. To date, I am completely symptom free and my “cankles” are gone.