Restenosis prevention continues to be a major challenge for the interventional cardiologists. This is because of inevitable limitations of the present technologies or therapies in preventing the recurrence of stenosis (narrowing of blood vessel). There are different types of cardiac stents such as drug eluting stents (DES) and bare metal stents (BMS) available for treating stenosis. Although drug eluting stents attenuated the level of cell proliferation and reduced the need for revascularization, there are risks related to late stent thrombosis and long term dependency on antiplatelet therapy. Moreover, these stents have provided relief to patients only to a certain extent as there is always a chance of in-stent restenosis. Therefore, the quest for new treatment options led to the development of drug eluting balloons (DEB). Drug eluting balloons have gained attention in recent years with growing awareness about its higher safety and efficacy than the present available treatment options.
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The drug eluting balloons market is in its nascent stage and is expected to witness substantial year on year growth as it reduces the risk of restenosis by releasing anti-proliferative drugs in the vessel wall. Presently, Paclitaxel is used as an anti-proliferative drug in the available drug eluting balloons. The drug eluting balloons market is analyzed in depth based on the indications for its use that includes:
In-stent re-stenosis (coronary)
Treating lesions in tortuous vessels (coronary)
Bifurcation lesions (coronary)
Acute myocardial infarction (coronary)
Femoral/Popliteal lesions (perpheral)
Below knee lesions (peripheral)
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These coronary and peripheral indications determine the demand for drug eluting balloons and the market can be understood effectively from this perspective. Use of drug eluting balloons in the peripheral and coronary artery diseases have proven effective in many cases. Yet, determining the long term efficacy of this technology is still under review and hence the adoption of this technology is restrained by this factor. Moreover, inadequate reimbursement for drug eluting balloons is deterring the market demand for this technology. Manufacturers are asked by the regulators to perform post-approval study to monitor the long term effects of drug eluting balloons. Stringent regulatory guidelines have restrained the rapid adoption of drug eluting balloons in the developed regions too.
The drug eluting balloons market is marked for rapid growth in the U.S., UK, Germany, Italy, France, Spain and Japan once adequate clinical information is furnished which affirms high potentiality of drug eluting balloons over other technologies. According to American Heart Association, in-stent restonosis still occurs in 10% to 40% of patients treated with stent implantation. Higher number of trials providing assurance for the safe and effective use of drug eluting balloons will lead to more and more approval of products based on this technology.
In addition, rising prevalence of coronary artery diseases, peripheral artery diseases, obesity, and diabetes will drive the demand for drug eluting balloons. Besides, the rising demand for effective therapies which will aid in reducing the complications associated with drug eluting stents will drive the demand for drug eluting balloons.
Some of the major players in the drug eluting balloons market are B. Braun Melsungen AG, Eurocor GmBH, Cook Medical, Inc., C.R. Bard, Inc., Medtronic, Inc. and Aachen Resonance GmBH.