Although narrowings below the knee continue to prove challenging, the drug-coated balloon (DCB) has demonstrated a nine-fold advantage over standard PTCA angioplasty balloons in the femoral-popliteal arteries. For example, in its pivotal study for gaining FDA approval, Medtronic's IN.PACT Admiral DCB showed sustained arterial opening at one year of 89.8% of patients, in contrast to 66.8% for the PTA non-coated balloon. And only 2.4% of patients needed a repeat procedure, compared to 20.6% for PTCA non-coated balloon.
So this week, Medtronic announced that it was investing $14 million to build a new 20,000 sq. ft. plant in Galway, Ireland, specifically to manufacture the IN.PACT drug-coated balloon. This project is a direct outgrowth of Medtronic's merger with Ireland-based Covidien, a company which had its own DCB, the Stellarex, which was sold off to Spectranetics as part of the requirements for the merger.
Several other DCBs are in various stages of the FDA-approval pipeline, and Bard's Lutonix is now being distributed by Boston Scientific, so competition in this market will be increasing: thus, Medtronic's decision to build this plant.
This week's press release from Medtronic, Inc. follows:
Medtronic Announces New High-Tech Facility in Galway; Building on Global Synergies
New facility to manufacture Medtronic's market- leading drug-coated balloons (DCB) technology
December 14, 2015 -- Dublin -- Medtronic plc (NYSE:MDT), a global leader in medical technology, services and solutions, today announced a new manufacturing facility in Galway, Ireland that will manufacture the market-leading IN.PACT® Admiral® drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD). PAD is a build-up of plaque in arteries throughout the body leading to reduced blood flow to the limbs, organs, and the brain. Patients with PAD are at higher risk for stroke and heart attack.
The decision to locate the new manufacturing facility in Galway is based on the existing high-tech capability and expertise at the site in drug-device combination products for Medtronic's coronary business. Highly skilled professionals from other parts of the Medtronic organization, approximately 100, who specialize in the areas of quality and manufacturing engineering, supply chain and production management, will be stationed in the new facility.
The announcement was made in Galway with a site-visit from Minister Richard Bruton TD, and Michael Lohan, Manager of Medical Technologies Division, IDA Ireland.
Minister Richard Bruton TD said: "Manufacturing is a key sector which we have targeted as part of the Action Plan for Jobs, and over the past four years we have seen the sector perform well after years of neglect. The investment in Galway today by Medtronic is a great example of the type of manufacturing projects we are trying to develop in Ireland - highly-skilled jobs, manufacturing innovative products, for sale in global markets. I wish Tony and the team every success with this project."
Martin Shanahan, CEO, IDA Ireland said: "This announcement once again showcases Ireland's position as a global hub for medical technologies, with this country employing the highest number of medical technologies personnel per capita in Europe. We have worked over a period of time with Medtronic to bring this capability and project to fruition in Ireland. The decision by Ireland and the IDA several decades ago to attract major medical and other technology companies to Ireland via state investment and support infrastructure continues to enable Ireland to reap the benefits."
Tony Semedo, senior vice president and president of the Aortic & Peripheral Vascular business at Medtronic, stated that the investment showed Ireland's importance to Medtronic's overall growth strategy.
"Since launching the IN.PACT Admiral DCB in the U.S. market, it has quickly become the fastest adopted DCB technology. In fact, our global market leadership in DCB is driving the need to open the new facility here in Galway to provide more patients access to this highly efficacious and safe treatment option for peripheral arterial disease. Our Galway operations and staff have very specific expertise in this area, which is the platform for this announcement. Once fully operational, this facility will be the only DCB manufacturing area of its kind in Medtronic worldwide. Our organization is on an expansionary path, with a notable amount of this growth to be fueled by products coming out of Ireland."
Medtronic continues to see additional synergies since the acquisition of Covidien. With the IN.PACT Admiral DCB U.S. launch the week following the acquisition, Medtronic was able to leverage the combined sales force to get this product to market faster.
The facility will have 20,000 square feet of space with 8,000 square feet dedicated to manufacturing and will cost approximately €13 million. It has been specifically designed to meet the needs of the manufacturing process associated with the IN.PACT Admiral drug-coated balloon (DCB), which is used for the interventional treatment of peripheral artery disease (PAD) in the upper leg. This is a serious and common cardiovascular condition that affects more than 202 million people worldwide.
About IN.PACT Admiral Drug-Coated Balloon
IN.PACT Admiral drug-coated balloon (DCB) is designed to reopen superficial femoral and popliteal arteries that have been narrowed or blocked by plaque. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the paclitaxel drug is intended to prevent artery narrowing by minimizing scar tissue formation.
IN.PACT Admiral DCB received the CE (Conformité Européene) mark in 2009 and approval by the U.S. Food & Drug Administration in December 2014. It is the most studied drug-coated balloon to date. Medtronic is conducting four Medtronic-sponsored studies, which include IN.PACT SFA, IN.PACT Global, IN.PACT Japan and IN.PACT China to assess the safety and effectiveness of the IN.PACT Admiral DCB. In addition, Medtronic is supporting approximately 20 physician-initiated DCB studies. In total, data on more than 4,000 patients treated with the IN.PACT Admiral DCB will be available.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Medtronic employs over 3,000 people in Galway, broken across its Parkmore Business Park West and Mervue facilities. The company has more than 4,000 employees overall in Ireland.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
