Covidien plc’s Stellarex™ Drug-Coated Angioplasty Balloon Receives CE Mark To Treat Peripheral Arterial Disease Patients

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

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).

“Comparison of Global Estimates of Prevalence and Risk Factors for Peripheral Arterial Disease in 2010: A Systematic Review and Analysis.”

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 Lancet, 40.5 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 percent. Additionally, the study showed 87.9 percent freedom from target lesion revascularization at 12 months and 85.8 percent 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.

About Covidien

Covidien is a global health care leader that understands the challenges faced by providers and their patients and works to address them with innovative medical technology solutions and patient care products. Inspired by patients and caregivers, Covidien’s team of dedicated professionals is privileged to help save and improve lives around the world. With more than 39,000 employees, Covidien operates in 150-plus countries and had 2014 revenue of $10.7 billion. To learn more about our business visit www.covidien.com or connect with us on Twitter.

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):1329-40.

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