Ireland-based leading healthcare products maker Covidien plc (COV) reported that the U.S. Food and Drug Administration’s (“FDA”) advisory panel for neurological devices has unanimously recommended the approval of the company’s “Pipeline Embolization Device” for treating large, giant and wide-neck cerebral aneurysms (a brain vascular disorder). The panel’s decision follows the review of the Premarket Approval (PMA) application data for the device.
The Pipeline Embolization Device has CE Mark approval in Europe and has been marketed outside the U.S. since July 2009. Covidien obtained the Pipeline Embolization Device through its $2.6 billion acquisition of endovascular devices maker ev3 Inc in July 2010. ev3 filed the final module of the PMA application for the device with the FDA in May 2010, containing a comprehensive review of the positive clinical data which achieved safety and effectiveness endpoints. The FDA granted an expedited review to the PMA in June 2010.
Cerebral aneurysms is a condition manifested by the dilation of blood vessel in the brain due to weakness in the wall of a cerebral artery/vein. If left untreated, the bulging vessel can pressure the surrounding brain tissues/nerves or may leak or rupture, resulting in brain hemorrhage.
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 is a leading global healthcare products company that develops and markets medical solutions for better patient outcomes. The company’s core medical devices business faces stiff competition from Johnson & Johnson (JNJ), Becton Dickinson (BDX) and C.R. Bard (BCR). Covidien boasts a well diversified product and technology portfolio.
The company 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 Covidien’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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