The Food and Drug Administration (FDA) has approved Medtronic Inc’s new “baby” Integrity; a new, more flexible, artery-bracing bare metal stent.
The world’s largest medical device maker Medtronic Inc., based in Findley, MN reports that that the new stent, made from continuous sinusoid technology, will eventually lead to the development of breakthrough devices like polymer-free drug filled stents (DFS).
The first FDA approved stent was developed in 1994 and immediately became a popular and preferred treatment for blocked coronary arteries, side-effects and issues with restenosis often requiring emergency coronary artery bypass graphing (CABG) not withstanding. In 2004 FDA approval of paclitaxel-eluding stents (DES), metal stents which release a drug designed to limit the growth of neointimal scar tissue reducing the risk of restenosis jumped ahead as the new best treatment for arterial blockage.
Coronary artery disease is a condition in which plaque, made up of fat, cholesterol, calcium and other substances, builds up inside the coronary arteries and is also known as atherosclerosis. Plaque narrows the arteries and reduces blood flow to your heart muscle making it more likely that blood clots will form in your arteries, partially or completely blocking blood flow.
During the procedure, angioplasty, a catheter is threaded into a small incision in the groin and up into the patient’s artery where a balloon inflates crushing the plaque and the stent is squeezed into place. Stents are mesh-metal tubes designed to hold arteries open after they have been cleared of the plaque.
Unique to the Integrity is the continuous sinusoid technology enabling the stent to be made from a single wire rather than a flexible spring, allowing doctors to deliver the stent which conforms better to vessel walls without compromising the strength of the device.
Currently, DES stents contain polymer coating, which can degrade causing inflammation, poor healing and clotting. Today, scientists are researching bioreabsorbable materials that can safely break down in the body.
With the help of nanotechnology, scientists are developing metal coatings with tiny holes to better control the drugs release into the arterial wall. This technology is expected to allow cells to absorb higher concentrations of the drug over time, further reducing restenosis and the need for the oral anti-clogging medication Plavix.
“Clinicians clearly appreciate the superior deliverability of the Integrity stent,” Sean Salmon, Vice President and General Manager of Medtronic’s coronary and peripheral division, said in a statement. “They are also intrigued at what else might be possible with continuous sinusoid technology, including the potential for a drug filled stent, which could obviate the need for a polymer to regulate drug elution by using holes on the surface of a hollow tube.”