Arteries become diseased when fatty tissue is deposited inside the artery walls followed by the buildup of plaque lesions, either soft or hard. Hard plaque is due to the deposition of calcium salts from blood into the fatty layer. Plaque accumulation causes the lumen of the blood vessel to reduce, and the stenosed vessel slowly loses its capacity to function as a blood channel.
Initial treatment of this condition was achieved with balloon angioplasty, pushing a balloon while deflated across the narrowed area. The balloon was then expanded to push out the vessel walls laterally, providing space for blood flow again. The next improvement came with the use of bare metal stents (BMS), where angioplasty was performed to bring about free vessel dilatation, after which another balloon was pushed through carrying a metal stent. This device was expanded and left in place to hold the stenotic spot open, so that blood could flow freely.
The complications of BMS were not long in appearing. One was the formation of neointimal layer hyperplasia, both inside the stent and around it, as a result of the body naturally attempting to cover the metal of the stent with endothelial cells. This effectively defeated the purpose of the stent as the new growth severely reduced the vessel lumen.
Drug Eluting Stents
Another step aimed at correcting the vessel blockage associated with neointimal hyperplasia: the development of drug eluting stents (DES), which release drugs designed to oppose this overgrowth immediately following the stent implantation. Thus they were capable of preventing the blockage observed to occur even after stenting was carried out.
Following this, the medical industry has been pursuing the development of a device which combines the stent’s ability to keep the artery open and the drug delivery system as required to regulate the response of the body to the foreign body within the blood vessel, in an optimal manner.
The need for the artery to heal to as close to the normal state as was feasible was also considered in this process. As a result the BRS was produced, meant to be implanted within the artery and left there for slow resorption by the body, leaving sufficient time for the artery to heal in its re-expanded state so that the stent was no longer needed. This resolves a number of problems posed by the earlier stent, as shown in Table 1.
Potential Benefits of BRS
Metal stents were standard when acute vessel occlusion occurred following balloon angioplasty. This was because they were strong and inflexible, keeping the lumen open. BRS maintains this advantage but avoids the needless hyperplasia and resulting vessel narrowing, causing it to heal in a constricted fashion.
Balloon angioplasty also had limitations in the form of inability to deliver drugs to prevent such sequelae. Whilst DES overcomes this problem, the stents are still foreign bodies, capable of provoking the body’s usual inflammatory response. Hence the issue is better addressed by BRS, because of the resorption of these devices which prevents the occurrence of hyperplasia in the long term.
Another advantage of BRS is the increased remodeling that is possible, unlike either stenting or angioplasty. It is true that balloon angioplasty allows more remodeling to occur than either BMS or DES, but BRS is resorbed, allowing the arterial wall to be remodeled under more natural conditions, spurred by the normal wall motion in response to the pulsatile flow of blood, with the stress conditions that are part of normal vascular physiology.
Table 1. Potential benefits of BRS (+ Prevented or not restricted; – not prevented or restricted; NA not applicable because of absence of stent).
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History of Zeus Inc
Frank P. Tourville, Sr. worked in the polymer extrusion industry for ten years before creating Zeus from a desire to “do it better.” While Zeus quickly established itself as a world leader providing high-performance polymer extrusions and solutions, their rapid, sustained growth is rooted in a commitment to improving industries and lives.
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