Silk Road Medical ENROUTE® Transcarotid Neuroprotection System

To incorporate the flow reversal technology, the Enroute design is an assembly of tubes and a handheld controller which also contains the filter. This controller is the primary interface for the surgeon conducting the treatment. After the procedure the controller filter can be opened up for plaque inspection. The controller incorporates a Stop button for X-ray contrast injection, and a Hi/Lo toggle button which gives surgeons control of blood flow rate. A large orange arrow always reminds surgeons of the flow direction away from the brain, a feature they highly desire! The system relies on blood pressure to move blood through it, so there are no motors or electronics, just simple "plumbing"!

When plaque builds up in the Carotid arteries it reduces blood flow to the brain and if dislodged can cause a stroke. The standard procedure is to introduce a stent via the femoral artery in the groin, or with risky open artery surgery. These methods can dislodge plaque and cause an embolism. Enroute is a surgical method that limits these risks. A small incision is made in the neck to introduce a catheter, then the carotid artery is tied off below the incision which causes the blood to flow in reverse, away from the brain. During stenting blood and plaque flow out of the body through the Enroute system where a filter captures the plaque. Clean blood is then reintroduced into the body through the femoral artery

Enroute provides protection for the patient's brain during the entire stenting procedure. What makes it safe is that it uses a "reverse flow” method that moves blood and plaque away from the brain and into a filter outside of the body. The biggest safety feature in our design is the large orange arrow on the filter/controller that always reminds surgeons of the flow direction away from the brain. Also, the Silk Road procedure can be performed using local anesthesia which allows for real time monitoring of brain function during the procedure. A smaller incision allows for minimization of wound complications, reduced scarring, and reduced risk of injury to the cranial nerves due to a safer incision location.

This product is a disposable unit because it comes into contact with the patient's blood, so it is considered a bio waste. Every effort was made to make this device as small as possible in order to consume as little material as possible.

Materials include medical grade PC/ABS; silicone tubing; polycarbonate lures and stopcocks. Most parts are injection molded or extruded. The system is hand assembled and placed in flat package.

Enroute has received much attention and adoption since its release. Vascular surgeons laud its ease of use and novel way of solving the problem. Not a single stroke event has occurred in the use of Enroute.

Enroute is a totally new way to perform carotid artery stenting, designed to save lives by minimizing procedural risks. What makes it so unique is that it uses a "reverse flow" technology. In carotid artery surgery, the arteries are clamped above and below the blockage to block blood flow and prevent plaque from traveling to the brain during treatment. Enroute isolates the blockage from forward blood flow by actually reversing blood flow away from the brain and capturing plaque in a filter outside the body. In addition, using the Enroute Transcarotid Neuroprotection System allows for local anesthesia and smaller incisions, leading to speedier recovery times and minimal potential complications.