OEM News, Regulatory

Boston Scientific Earns CE Mark for Ranger Paclitaxel-coated PTA Balloon Catheter

Full EU launch will begin immediately.

Boston Scientific Corporation has earned the CE mark for its Ranger Paclitaxel-coated PTA balloon catheter, and is proceeding with a full European market launch immediately.
  
According to Boston Scientific, the new and advanced drug-coated balloon (DCB) catheter will enrich the company’s portfolio of peripheral vascular disease products besides strengthening the company’s foothold in Europe.
  
The Ranger DCB is an additional option for the treatment of peripheral artery disease. It delivers an anti-stenotic drug to the unhealthy vascular tissue while leaving behind no permanent implant. Further, it offers a radical option to treat both above-the-knee and below-the-knee lesions.
 
According to a reliable source, in using traditional technologies, physicians end up losing a significant portion of drug coating during the handling, insertion and placement of the device. The Ranger DCB is so designed as to reduce pertinent drug loss while optimizing both deliverability and the absorption of the drug in the targeted tissue.
 
Peripheral artery disease (PAD) is a circulatory disorder resulting from a build-up of plaque in one or more arteries, most often in the legs. With the aggravation of PAD in a patient, plaque accumulation may reduce blood flow through the arteries significantly. This may result in pain and increasing disability with severe cases even leading to amputation of the affected limb.
 
In recent times, PAD has become a major cause of worry all over the world. Recent data show that 12−14 percent of the general population is affected by PAD, which makes Boston Scientific’s CE mark timely. The company expects to capture significant EU market share in this geography.
 
The peripheral interventions business of Boston Scientific has been delivering above-market growth in the last few quarters driven by strong international and emerging market performance. According to the company, this consistent success is driven by its leadership positions in balloons, stents and interventional oncology.
 
Growth in the United States has been driven by the Epic stent (a self-extending Nitinol stent ideal for iliacs launched in 2012), the carotid wall stent, and the direction micro-catheter for the delivery of diagnostic or therapeutic material, which was launched in the fourth quarter of 2013.
 
Based in Marlborough, Mass., Boston Scientific makes medical device in the interventional medical specialties market.

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