A California startup aims to make opening up of chronic total occlusions in the lower limbs easier thereby making the treatment of peripheral arterial disease more effective.
|CentraPass aims to treat chronic total occlusions more effectively|
Peripheral Arterial Disease affects 8 million Americans, according to the American Heart Association.
As plaque builds up, arteries narrow restricting blood flow to the lower limbs. In severe cases, when medication isn’t enough and the artery is completely occluded or blocked, a minimally invasive procedure is required to open up the artery. Otherwise, there is a risk of gangrene and even leg amputation.
The minimally invasive procedure involves opening up the CTO or chronic total occlusion through a guidewire followed by the placing of a ballon and stent, which allows blood flow to resume to the lower limbs.
But a physician-inventor believes the conventional method of opening the artery is not adequate. In fact he believes that it reduces the efficacy of the stent procedure and may require another intervention down the road.
“Chronic total occlusions are very challenging for physicians to treat with any existing devices because there is no way we can guide the wire to go through the blockage properly,” said Mallik Thatipelli, vascular interventionist, and CEO of TS3, a California startup founded in 2013.
The problem, he believes, lies with the design of these devices.
“Typically a wire is used to open the blockage,” Thatipelli said. “When there is complete blockage wires go through the sub-intimal spaces between the blockage and the artery wall, so it's very difficult to channel and guide the wire,” he said. “There is no way to control it. It can go anywhere and if you push the wire too hard, you can cause perforation and damage tissue.”
Thatipelli went on to add that there are four or five different types of devices currently in the market but their success rate is low, anywhere from 50% to 60%. In the hands of an experienced interventionist, the success rate can be 80%.
Having performed procedures to treat CTOs, Thatipelli felt that a simple and easy-to-use device needs to be developed with which even the novice vascular interventionist can achieve a high rate of success.
That led to his invention, CentraPass, which is is designed to be stabilized at the center of the blood vessel.
“When you are are pushing through the blockage, the device stays to the center and the device has a loop of wires instead of a wire with a sharp end,” he said. “The advantage of this self-centering device is that you don't have to navigate it.”
He added that compared to current products, such as the TruePath CTO device made by Boston Scientific, CentraPass requires less contrast and the patient is exposed to less radiation. Current devices cost around $2,000, he said whereas he intends to price the device around $1,200.
Currently, Thatipelli is looking to raise around $10 million. If he is successful in raising the money he can conduct animal trials in the next six months and then apply for a 510(k) clearance as well as CE Mark for a commercial launch in 2015.
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