Drug coated baloons emerging as cheaper and safer option to stents for opening up heart vessel blocks

Drug coated baloons to open up blocked blood vessels in heart diseases is getting more popular as these are considered more effective and cheaper compared to stents, according to experts.

Compared to drug eluting stents, the drug eluting balloon is less expensive and are almost 40 per cent cheaper.

Apart from affordability to patients, drug coated baloons are found to be more safe and effective to treat blocks in the blood vessels around the heart through non-surgical intervention called angioplasty.

Cheaper drug eluting baloons can be considered a better alternative to drug eluting stents.

Several studies in patients conducted across the world have showed that drug eluting balloons are offering an ideal solution to treat conditions like peripheral lesions where stents cannot be placed, according to Praveen Dr Chandra, chairman, interventional cardiology, Medanta Heart Institute, Gurgaon, Haryana.

When tested in 100 patients suffering from heart vessel blocks, drug eluting baloons have found showing a clear edge over drug eluting stents.

Baloon angioplasty suing drug eluting baloons could overcome instances of blood clots (thrombosis) and stent fracture which are associated with drug eluting stents.

Stents are small wire meshes coated with a drug, also called drug-eluting stent (DES), is commonly implanted to widen the arteries so that blood flow is restored in patients suffering from blood vessel blockages in the heart.

Even though DES have been shown to be very effective in reducing restenosis and therefore the need for further reintervention, DES has been associated with a slightly higher risk of stent thrombosis that may occur even long after implantation. One of the reasons postulated is the presence of a polymer coating that is used to carry the drug on the stent and control its release from the stent.

Another challenge with stents is that the patients must continue to take blood thinning medications after angioplasties using stents to avoid blood clots in the vessels. With drug eluting balloons, the patient can even discontinue the the blood thinning medication as thiere is no stent is used to open up the vessels.

Drug eluting baloon technology started at about the same time drug eluting stents (DES) were being adopted in the US market. However, stents emerged to remain the ‘gold standard’ and baloons have been limited to niche applications.

From its inception, drug eluting baloon technology sparked widespread interest from both interventional cardiologists and interventional radiologists seeking improvements in procedural success and a reduction in lesion restenosis rates.

Although the most promising applications for the technology appear to be niche, especially for coronary applications, it is highly feasible that utilisation could easily spread with Drug eluting baloon technologies becoming a mainstream tool in the interventionalist’s repertoire, particularly for the treatment of peripheral artery disease.

Drug eluting baloon’s potential is highlighted by the number of companies known to be competing in this area, ranging from leading global players to small, highly specialised companies.

Elutax, by B. Braun Melsungen AG, SeQuent Please by Bayer AG (Medrad, Inc.), Cotavance by Caliber Therapeutics, Inc.,TADD (Targeted Angioplasty Drug Delivery) by Cook Group, Inc., Advance 18PTX by Eurocor AG, Dior by Opto Circuits Ltd, Invatec s.r.and In.Pact Amphirion are some of the drug eluting baloons currently in the market.

Currently, only a handful of companies have gained market approval for their products but, with the level of pre-clinical and clinical activity reported here, many more can be expected to enter the market in the near future.

Although the technology appears to hold such promise, there is still a strong need for further clinical evidence of each product’s capability, efficacy, and safety.

The criteria for gaining market acceptance must be clear as the drug eluting baloon holds much promise for the treatment of life-threatening vascular disease. It is imperative to allow this technology the potential for adoption by having safe and efficacious products developed within a fairly regulated environment, experts said.

India is among the countries which are reportedly having higher incidence of heart vessel diseases. The country currently  has nearly 600 interventional cardiologists.