Any natural or synthetic material used to replace, support, or enhance a biological function is called a Biomaterial. Biomaterials, typically inspired by their many uses in industry, are not considered drugs, but still require FDA approval.
The first use of biomaterials in medicine dates back to the early Egyptians who used animal sinew to create surgical sutures. Ironically, we still use this same technology in surgery today in the form of catgut suture. Although the name implies the use of “cat gut”, it is derived from the intestine of cattle, goats, or sheep.
Four other widely recognized biomaterials are: metal, ceramic, glass, and polymers. Examples of metals used in medicine are: titanium in knee/hip replacements or pacemakers as well as vascular stents made of stainless steel, nitinol, or chrome-cobalt alloy. Ceramics can be used in dental implants, bone replacement, and surgical cements. Surgical glass is used in ear implants, microchip case housing, and eye implants.
Polymers may be the most versatile of the biomaterials, and their use in medicine spiked as a result of the extensive casualties during World War II. For example, the cellophane used in sausage casings inspired the first artificial kidney crafted by Dr. Kloff. In 1952, Dr. Voorhees used sailcloth from leftover WWII parachutes to fashion an artificial artery. Another polymer used today in the vascular system is glue. One of the most recent glues added to our “medical toolbox” is Venaseal.
Venaseal is a cyanoacrylate glue used to seal-closed malfunctioning veins in the legs that were causing pain, swelling, and skin changes or ulcers (sores.) If the word “cyanoacrylate” sounds familiar, it is probably because you have a bottle of this in your home toolbox with a label that reads “Super Glue” or “Krazy Glue.” You may even have a bottle in your first-aid kit that reads “LiquidSkin” or “New Skin” that you use to seal small nicks and cuts.
Cyanoacrylate has been used in surgery as far back as 1950’s as a skin adhesive. In 2000, it began being used in the vascular system to embolize (seal closed) vascular malformations. One of the most common vascular malformations where the glue is used is in the brain. Cyanoacrylate glue is also used in heart surgery, gynecologic surgery, and gastric surgery. The most recent use of cyanoacrylate is in the treatment of a venous disease known as: chronic venous insufficiency (CVI). In CVI (typically an inherited disorder), there is a malfunction of the one-way valves, mainly in your minor vein system. This malfunction allows the blood to circulate in the wrong direction when the legs are dangling down (sitting or standing) causing your legs to ache, swell, change color, and/or develop varicose veins, skin darkening and worst of all… ulcers.
Venaseal cyanoacrylate glue is used to “seal closed” these malfunctioning veins. Venaseal works when it comes in contact with blood or plasma causing it to polymerize. The glue then triggers an inflammatory reaction in the vein wall resulting in closure of the malfunctioning vein. The blood can now correctly circulate in the remaining, properly functioning veins, allowing relief of symptoms and healing of ulcers.
Venaseal was given the green light by the FDA to treat chronic venous insufficiency in February of 2015. The process to obtain FDA approval is rigorous and long, and on average takes three-to-seven years. The road to FDA approval for Venaseal involved three clinical trials, including the VeClose Trial which was later extended to include 5-year follow up results. This study was headed up by Center For Vein Restoration’s very own Dr. Nick Morrison.
In addition to Venaseal glue, there are also: thermal technologies (laser and radiofrequency), chemical technologies (Varithena and sclerotherapy), and mechanical technologies (phlebectomy and Clarivein) to treat chronic venous insufficiency. These technologies all offer less painful, more convenient, office-based alternatives to the old-fashioned hospital-based vein stripping procedures.
It is important to have a fully stocked “medical toolbox” when treating venous disease. No two human bodies are the same, and different technologies will be better suited to different people. Center for Vein Restoration offers full spectrum diagnosis and treatment of venous disease to patients in a comfortable outpatient setting. Call us for a consultation either by telemedicine or in-person.
Regional Medical Director at Center for Vein Restoration and Center for Vascular Medicine
Dr. Deol is double board certified in general surgery and venous & lymphatic medicine. She is scientifically published; and she is also a national and international speaker/educator on venous and lymphatic disease. She currently practices in metro-Detroit and the greater Toledo area.