The next evolution in blood vessel occlusion

The good news for his patient was that she was young. A lower extremity bypass procedure - like any surgery - can be more difficult as we age. 

The bad news was that the best veins for the procedure - which involves grafting a vein from another part of the body to bypass her blocked arteries in the leg - were unusable. The patient had undergone varicose vein treatments as a young woman that had destroyed her leg veins, the best options for the bypass procedure.

Why do varicose veins procedures have to be so destructive and at the same time potentially ineffective for the varicose veins? There has to be a more elegant, simple and innovative solution. That was the frustration facing Dr. Arnold Miller, a vascular surgeon in 2010 when he founded Amsel Medical Corporation with his son, Raanan with a simple, elegant solution to provide a simple, secure, percutaneous, needle delivered localized, permanent mechanical occlusion of the targeted vessel, that did not destroy a long segment of the vein used for bypass surgery for blockages in arteries supplying the  extremities, the heart and other vital organs.

Simplicity 

That same year on another coast, Steve Jobs took the stage for what turned out to be his last major product launch. He let the world know that they had always wanted an iPad, they just hadn’t known it yet. 

Jobs agreed that phones weren’t ideal for surfing the web, even iPhones. But laptops weren’t optimal either. There had to be a better way. 

As Jobs pointed out - “Some people have thought that’s a netbook. The problem is that a netbook isn’t better at anything. They’re slow. They have low-quality displays. And they run clunky, old PC software [Windows]. They’re not better than a laptop at anything. They’re just cheaper.” 

Jobs unveiled an elegant, thin touch screen, simple and purpose-built for engaging the web cleanly and efficiently. At first observers asked why they needed an oversized iPhone, or laptop without a keyboard. That is, until they held one… and then understood. 

Not the first 

Just as Jobs’ iPad was not the birth of the computer. Amsel Medical did not invent blood vessel occlusion or ligation. 

The first recorded attempt to control bleeding vessels by ligation dates back 3,000 years. The principle of ligation is attributed to Hippocrates and his disciples in Ancient Greece around 500 BCE. 

Little medical innovation occurred during the fifth to 15th centuries where the standard for wound hemostasis was cautery. Bleeding wounds and vessels were commonly burnt with heated oils. Barber Ambroise Pare in the mid-16th century reintroduced ligation and discouraged the use of cauterization with hot iron or boiling oils. He also developed what was likely the first vascular clamp.  Ligation of blood vessels with various suture materials permitted the development of modern surgery.

Mechanical vessel occlusion with clips and staplers was introduced in the latter half of the 20th century and remains a core occlusion method in current surgical practice. 

Electrical means of vessel occlusion have also gained traction. Electrosurgical methods were introduced in the early part of the 20th century mostly for neurosurgical procedures on the brain. Today Electro-surgery is widely used beyond the brain, and even to occlude medium sized blood vessels. More recently, ultrasonic occlusion has been successfully introduced into surgical practice for occlusion of blood vessels. While for many procedures electro-surgical or ultrasonic techniques are attractive, there are numerous procedures where due to contact area constraints or criticality of the occlusion, the security of permanent mechanical occlusion is a priority.

The Ligaclip was developed in the 1950’s as a simple mechanical method to occlude blood vessels and avoid the necessity to tie off the vessel with a thread. The ligaclip is similar to a “paper” clip with a potential to fall off, with often devastating effects of the subsequent bleeding. To overcome this, staplers were introduced in the U.S. in the early 1980’s. Neither the ligaclip or stapler can be applied percutaneously through the skin.

Mechanical occlusion with Amsel SCureClamp, which transfixes the targeted vessel, similar to a transfixion suture, avoids the problem of displacement common to the ligaclip and occlusion is  permanent. It does not rely on the body’s response to thermal or chemical treatments currently in practice (lasers, RF, glues and sclerosants) for treating varicose veins. It avoids the problem of “recanalization” (creating new channels) of the occluded segment common to all these occlusion therapies, which results in a failure to permanently occlude the targeted vein.

Building insight 

Dr. Miller grew up in South Africa and did his medical training in South Africa, England and Canada before coming to the United States. He practiced clinically as a vascular surgeon for over 45 years before retiring from MetroWest Medical Center and the Massachusetts General Hospital in Boston. 

During his career he had been a pioneer in angioscopy and invented multiple vascular surgical devices and came to hold multiple patents. He had published 49 original articles in prestigious medical journals and has written 20 book chapters. Dr. Miller worked with multiple medical device companies developing new state-of-the-art applications.  

What comes next 

For the next chapters in the story, including the U.S. Air Force, special forces, and a procedure delivered through a tiny needle, come to the Amsel Medical site, and join us for what’s coming next, later this year!