The FDA (Food and Drug Administration, USA) has approved Medronic's Integrity Coronary Stent System, based on an advanced biomedical engineering called continuous sinusoid technology, enabling the exploration of other new device concepts, such as a polymer-free drug-filled stent. The stent is said to feature a new, more flexible construction which is easier for surgeons to insert.

A stent is a metal mesh which is placed inside an artery after it has been cleared of blockage, to stop that part of the artery from narrowing.

According to Medronic, the makers and marketers of the Integrity Coronary Stent System, it has been demonstrated in bench testing and blinded in vivo doctor assessment studies to be highly deliverable - the device can traverse the patient's vasculature and reach the targeted narrowed heart artery for treatment.

Dr. Mark Turco, director of cardiac and vascular research, Washington Adventist Hospital in Tacoma Park, Md., said:

The Integrity stent system sets a new gold standard for deliverability thanks to the advance of continuous sinusoid technology. This new platform negotiates the twists and turns of the coronary anatomy remarkably well. Credit goes to Medtronic for continuing to improve stent technology, as continuous sinusoid technology should prove to be an excellent platform for future product development.

Dr. Turco was one of the first interventional cardiologists in the USA to use the Integrity Coronary Stent System in clinical practice.

With continuous sinusoid technology each stent is made from a single wire, unlike other stents that are made from rings of cobalt alloys - like a flexible spring. Along with the MicroTrac delivery system, it offers exceptional deliverability without compromising vital stent design characteristics, such as radial strength. The integrity stent, like the Driver stent, is also very conformable - it can conform to the natural shape of the vessel.

The Integrity Coronary Stent System received the CE (Conformité Européene) mark in February 2010. It is currently available in about 100 countries around the world.

Sean Salmon, vice president and general manager of Medtronic's coronary and peripheral division, said:

Clinicians clearly appreciate the superior deliverability of the Integrity stent. 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.

Source: Medtronic