Leading healthcare products maker Covidien plc (COV) has secured Premarket Approval (“PMA”) from the U.S. Food and Drug Administration’s (“FDA”) for its Pipeline Embolization Device for treating adults (22 years and above) with large, giant and wide-neck cerebral aneurysms (a brain vascular disorder). The approval follows the unanimous recommendation of the FDA’s advisory panel in March 2011.
Covidien obtained the Pipeline Embolization Device following its $ 2.6 billion acquisition of endovascular devices maker ev3 Inc in July 2010. The device has CE Mark approval in Europe and has been marketed outside the U.S. since July 2009. According to Covidien, it will be available at the existing clinical sites in the U.S. shortly.
Cerebral aneurysms is a condition manifested by the dilation of blood vessels in the brain due to weakness in the wall of a cerebral artery/vein. According to the National Institute of Neurological Disorders and Stroke (“NINDS”), it is mostly prevalent in people aged between 30 and 60 years.
If left untreated, the bulging vessel can pressure the surrounding brain tissues/nerves or may leak or rupture, resulting in brain hemorrhage. A ruptured cerebral aneurysm affects roughly 30,000 Americans each year.
Currently, surgery and endovascular treatments are widely used to treat cerebral aneurysms. However these are associated with risks such as potential damage to surrounding blood vessels, disease recurrence and post-operative stroke. As such, there remains a major unmet medical need for the treatment of cerebral aneurysms.
The Pipeline Embolization Device, following its implantation, works by diverting blood flow from an aneurysm. Based on the clinical study results, the device appears to be a safe and effective alternative to the existing treatment options for treating cerebral aneurysms. The worldwide market for aneurysm treatments may potentially reach roughly $ 350 million by 2013.
Covidien boasts a well diversified product and technology portfolio. Its core medical devices business faces stiff competition from Johnson & Johnson (JNJ), Becton Dickinson (BDX) and C.R. Bard (BCR).
Covidien remains committed to rolling out new products and technologies, focusing on fast-growing markets, and boosting market share in core segments through investments in sales and marketing infrastructure. The acquisition of ev3 has pushed the company’s leadership up in the endovascular devices market giving it a strong foothold in both the peripheral vascular and neurovascular sub-segments.
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