CORACTO PROJECT
To watch Prof. Dr. Nicolaus Reifart announce the results of the Coracto Study, please click here
CORACTO DES (Drug-Eluting Stent) is manufactured with CE certificated and bio-compatible raw materials. These materials do not interact with the body fluids chemically and do not harm the body.
316L coded Stainless Steel is the main material of bare metal stents and has been used in stent manufacturing for many years.
Rapamycin is the drug selected for coating the bare metal stent. For many years the Rapamycin molecule has been used to prevent tissue rejection in surgeries like kidney and heart transplants. Also it has been used in stopping the uncontrolled cell reproduction in cancer treatment. This molecule’s preventive effect on restenosis (re-narrowing formed inside of the stent after the implantation caused by uncontrolled cell reproduction - a negative incident observed in some patients) has been clinically proven. Rapamycin is an immunosuppressant molecule. With this feature, Rapamycin prevents smooth muscle cells (the most important factor that causes restenosis) from getting activated and from uncontrolled reproduction. The molecule does not harm the surrounding cells but prevents mitosis cell cycle from the start, thus prevents restenosis.
The drug covering Constant™ bare metal stent is loaded on the polymer with special techniques. Following the release of the drug in a certain period of time and its consumption by the body, the polymer fulfills its duty of encapsulating the drug. Then it starts degrading and transforming into byproducts that are easily metabolized and dissolved in the body.
The Constant™ bare metal stent that we recently developed is one designed specifically to provide exceptionally high performance and flexibility in compatibility with the vessel’s shape. Similarly, The Turquoise™ Balloon Catheter, that CORACTO stent is crimped on, is a catheter facilitating the access to the vessel’s problematic area and is extremely flexible and highly compatible with the vessel’s shape. Thus, by the co-utilization of two separate materials good at vessel compatibility and flexibility, a synergy is created. As a result, a new product has emerged providing doctors with a great ease of use during the application, and consequently creates a high clinical value and increases patient adaptation rates.
The significant part of the histopathological studies carried out on the drug-eluting stent projects -which are currently sold worldwide or researched to be marketed later on- are conducted by CVPath, an organization located in Maryland, USA. The histopathological studies conducted at this research center -which is administrated by Dr. Renu Virmani (M.D.) - on drug-eluting stents are accepted worldwide.
Endothelialisation (the period of natural tissue formation by means of coating of the stent’s interior surface with the interior vessel wall cells) is a very important factor in terms of the stent’s reliability and success. Thus, the body perceives the stent as if it is its own tissue and gives up protecting itself by rejecting it. The body cures itself and as a result bleedings inside the vessel stops. When the bleeding stops the risk of clotting disappears as well. Consequently, risks such as the heart attack or paralyses - resulting from capillary occlusion stemming from clot-thrombus formation - are minimized.
The histopathological studies of CORACTO (Rapamycin eluting stent) were carried out at this center and very satisfying results were obtained. Additionally, the results of the animal study were also pleasing. The difference between this study and the animal study –which was conducted by cardio-histopathologs- is the examination of restenosis instead of endothelialisation. These studies have been carried out exactly as they were specified in the CE Quality Standard. When the significant decrease in the restenosis (re-narrowing) rates, which is an occurrence that may happen after the implantation of the drug-eluting stents compared to bare stents, are taken into consideration, this study is a prerequisite for demonstrating the efficiency of the CORACTO stent.
The drug delivery system of CORACTO stent is different from its competitors in the market because it is made of a biodegradable polymer. Thus, after the operation, the polymer separates into its monomers and disappears by decomposing inside the body within a certain period of time. Due to its drug release system, restenosis is prevented from happening. In the studies conducted, stent’s drug release profile demonstrates that the desired endothelialisation takes place. Due to these features, patients do not have to be treated with anti-platelet therapy for a long time – as is the usual case with other competing products.
This feature will make CORACTO usable on patients who are not suitable for anti-platelet treatment or who are going to undergo another operation within a short time span. This is because whilst the anti-platelet treatment is used for clotting and for the prevention of pertinent risks that occur, it puts the patient temporarily in a hemophilic condition in a controlled manner. In other words, the blood becomes highly liquified and hence cannot be easily stopped in case of bleeding. Such a condition is the most serious side effect which affects the quality of life of the persons pursuant to the implantation of other drug-eluting stents of this type in the market.
The dissolution of the polymer pursuant to the completion of the drug release in CORACTO ensures stent’s adaptation to the body within the shortest time. Thus, the drug integrated with the stent eliminates the reasons for the disease. Afterwards, the polymer, which carries the drug, disappears and this particular function prevents the side effects of additional medication treatment. Along with its positive biological effects, the implantation of Coracto also lifts a certain amount of economic burden from the patients’ shoulder by guarding them from the excessive cost of a long-term medication treatment.