EuroCor Life Sciences, a subsidiary of Opto Circuits has launched the blockbuster device DIOR, the first and only CE-marked Drug (paclitaxel) Eluting Coronary Balloon Dilatation Catheter used in Coronary Angioplasties. The device is less risky, cost-effective and minimally invasive treatment option for some worst-case scenarios arising out of clogged coronary arteries.
DIOR is introduced into an artery through a guidewire; once inside, it dilates the artery to clear out plaque formation around the block, it releases the drug and is then withdrawn from the body. Treatment with DIOR does not necessitate the permanent placement of a foreign object within the patient's body for many patient cases, as it is done when a Bare Metal Stent (BMS) or a Drug Eluting Stent (DES) is used. Also, unlike a DES that elutes a drug over a period of 90 days, DIOR releases paclitaxel in 30 seconds (which acts with decreasing efficacy over a period of 5 days), thereby significantly reducing the need for long term antiplatelet drug therapy. This also makes DIOR a convenient treatment for high-risk and non-compliant patients.
The DES is the least minimally invasive therapeutic approach to deal with stent-associated adverse issues: in-stent restenosis (re-clogging of a coronary artery after the placement of a bare metal stent; 22-25 per cent of all such cases) and late-stent thrombosis (blood clotting occuring out of the presence of a polymer and the delayed healing of the arterial wall after the placement of a drug-eluting stent; 10-15 per cent of all such cases). It optimises long-term BMS results by delivering a drug to counter the re-formation of plaque within the treated artery. DIOR is also a formidable alternative to a stent in managing blood flow through lesions in bifurcated arteries and through small lesions and small arteries.
According to Dr Shirish Hiremath, interventional cardiologist, Ruby Hall Clinic, DIOR will become an indispensable device for every Cathlab performing coronary angioplasties today. It has revolutionized the angioplasty landscape by giving birth to a whole new family of alternative interventional treatments. It is a boon to patients who may not be able to afford expensive anti-platelet drugs in case of a traditional stenting procedure.
The device has been tested in more than 7000 patients through 8 ongoing international multi-centre clinical trials; preliminary results from these are excellent and have been published in leading medical journals around the world. In India, 100 patients were enrolled to compile the DIOR registry. The product is approved by the Drug Controller General of India in January 2009.
The device was recently found to be a path-breaking application in treating aortic valvuloplasty too. This method has been found to be a boon for patients who are poor candidates for surgical or transapical valve replacement. Such a first-in-man experiment was successfully performed in Greece during the Athens Interventional Cardiovascular Therapeutics (AICT) September 2008 Convention. Thereafter, the concept was presented at the world's largest educational meeting for interventional vascular medicine - Transcatheter Cardiovascular Therapeutics (TCT) October 2008 Convention in Washington DC. Here, DIOR received the most encouraging response in the Innovative Devices and Futuristic Concepts session.