Cardiovascular disease (CVD) is the number one killer in the western world and accounts for an estimated half a million deaths annually in the U.S. and for over 2 million deaths annually across Europe. The American Heart Association (AHA) estimates that 25% of the U.S. population has one or more types of CVD.

The international gold standard technique for the diagnosis and treatment of CVD is Angiography, based on X-ray technology. The major disadvantages of angiography are its low resolution and the fact that it only provides 2D view of the lumen and cannot provide an intravascular picture. Angiography requires the injection of a contrast agent to the patient’s vascular system. The procedure must be performed repeatedly prior to, during and following angioplasty treatment while keeping X-ray irradiation to a minimum. These factors limit the extent to which angiography can aid during angioplasty treatment, requiring that the physician inserts the guidewire and chooses balloon and stent size based on partial information only. Furthermore, existing angiography does not provide useful information regarding the correct position or optimal deployment of implanted stents.

However, successful treatment outcome, lower rate of restenosis (occlusion recurrence) and avoidance of serious complications like Late Stent Thrombosis are contingent upon accurate choice, positioning and deployment of stents. Recent findings presented at TCT 2006 demonstrated that geographic miss occurs in 66.5% of angiography-led stent implantations. Furthermore, 77% of DES (Drug Eluting Stent) patients reporting Late Stent Thrombosis displayed incomplete stent apposition.

Bioscan combined laser and ultrasound operating within a fiber optic, allowing its integration into a standard 0.014" (1 F) angioplasty guide-wire. This gives the guide-wire the ability to perform not only as a rail for balloons and stents, but also as an imaging device, allowing it to make accurate measurements of lumen, stent and EEM (External Elastic Membrane) diameters and to present to the physician a reconstructed vessel picture before and after treatment in real time.

BioScan’s unique technology, based on the already proven and safe ultrasound technology, will therefore enable the physician performing the PTCA procedure to view the occlusion area, size the stent, guide the stent precisely and view the deployed stent, all in real-time, at low cost and without adding additional steps to the existing procedure.

LightWire is handled and utilized like a regular guidewire, and therefore does not require any special physician training. The utilization of LightWire does not add any additional steps to the regular procedure as it does not require repeated insertion and extraction of a specialized imaging device. The full functionality is included in the guidewire. Interpretation of LightWire displays is easy and straightforward and does not require special training.

No existing products in the market meet these features.