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Covidien’s Stellarex Drug-Coated Angioplasty Balloon Receives CE Mark to Treat Peripheral Arterial Disease

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Covidien’s Stellarex Drug-Coated Angioplasty Balloon Receives CE Mark to Treat Peripheral Arterial Disease

01/12/2015

Stellarex DCB featuring EnduraCoat technology designed to restore blood flow and prevent formation of new blockages

January 08, 2015 04:05 PM Eastern Standard Time

DUBLIN, Ireland--(BUSINESS WIRE)--Covidien plc (NYSE:COV) today announced it has received CE Mark approval for its Stellarex drug-coated angioplasty balloon (DCB). The Stellarex DCB is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease (PAD).

“In clinical trials, the Stellarex DCB has demonstrated promising results with strong patency rates and low reoccurrence of target lesions at 24 months.”

The Stellarex DCB is inserted into the diseased artery and inflated to open the vessel and restore blood flow, while a drug called paclitaxel is deposited onto the vessel wall to prevent the reoccurrence of new blockages. The Stellarex DCB’s proprietary EnduraCoat technology provides a durable, uniform coating which reduces drug loss during transit and facilitates efficient drug delivery to the treatment site.

According to The Lancet40.5 million cases of PAD were reported in Europe in 2010.1 PAD occurs when arteries in the legs become narrowed or blocked by plaque. These blockages (lesions) can result in severe pain, limited physical mobility, non-healing leg ulcers and leg amputation. Patients with PAD also have an associated higher risk of heart attack, stroke and death.2

“PAD is a progressive disease that affects millions of people around the world. DCBs are emerging as an alternative to traditional treatment options, such as angioplasty or stenting, because of their ability to restore blood flow, prevent the reoccurrence of new blockages and preserve future treatment options,” said Dr. Henrik Schröeder, radiologist, Vascular Center-Jewish Hospital, Berlin, Germany, and principal investigator, ILLUMENATE FIH Study. “In clinical trials, the Stellarex DCB has demonstrated promising results with strong patency rates and low reoccurrence of target lesions at 24 months.”

The 24 month results of the ILLUMENATE First-in-Human (FIH) study demonstrated a primary patency rate (ability to keep the artery open to restore blood flow) of 80.3%. Additionally, the study showed 87.9% freedom from target lesion revascularization at 12 months and 85.8% at 24 months.

On November 2, 2014, Covidien announced it had entered into a definitive agreement with Spectranetics Corporation under which Spectranetics will acquire Covidien’s Stellarex DCB platform. The transaction is subject to the closure of the pending acquisition of Covidien by Medtronic, which is expected to occur in early 2015.

References

1. Fowkes, et al. “Comparison of Global Estimates of Prevalence and Risk Factors for Peripheral Arterial Disease in 2010: A Systematic Review and Analysis.” The Lancet. 2013 October 19:382(9901):1329-1340.

2. National Institute of Health. Stay in Circulation: Facts about Peripheral Artery Disease.http://www.nhlbi.nih.gov/health/educational/pad/materials/pad_extfctsht_general.html

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