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Medtronic to launch new Defender embolic protection filter in Europe

Medtronic : 17 April, 2008  (New Product)
Medtronic has announced CE mark approval and the European market launch of the Defender embolic protection filter for use during minimally invasive procedures in carotid arteries and saphenous vein grafts.
The first uses of the new Defender filter were recently completed by interventional cardiologists and vascular surgeons in Germany and Spain.

Worldwide, hundreds of thousands of patients undergo cardiovascular procedures each year – many involving the implantation of stents – to improve blood flow.

Made of braided nitinol (a ‘memory metal’ that resumes its original shape upon deployment), the Defender embolic protection filter has a low profile and a peelaway delivery sheath that enables physicians to manoeuvre the device easily across lesions to the desired location. When opened, the filter acts as a basket, allowing sufficient blood flow while simultaneously trapping dangerous embolic debris that may become dislodged during the stenting procedure.

Without this protection, embolic debris can flow into other portions of blood vessels – and, in the case of patients with carotid artery disease, this can lead to a stroke, one of the world’s leading causes of death and longterm disability.

The new Defender embolic protection filter is now available throughout the European Union, said Rob ten Hoedt, vice president of the CardioVascular business for Medtronic in Western Europe. CE Mark approval gives Medtronic the ability to market this device in European countries and other international markets. The Defender filter is not available in the USA.

“While designing the Defender filter, we conducted extensive research with physicians to understand their needs and what they felt were the most important qualities in an embolic protection device,” said ten Hoedt. “They told us they needed a filter that is easy to use, with excellent deliverability and a low crossing profile to minimise the risk of dislodging debris when they cross a lesion. The Defender filter is innovatively engineered to meet all those needs, even in patients with challenging and complex anatomies.”

“For me,” said Dr Andrej Schmidt from the Department of Clinical and Interventional Angiology at the Heart Center in Leipzig, Germany, “the most important attribute for a filter is its crossing profile, and Defender has one of the lowest profiles available on the market.”

The Defender filter has a 2.2 French (0.029inch) crossing profile and an extendable 0.014inch stainless steel core wire that is designed for both flexibility and support. Also, the device’s mesh filter basket design allows the filter to fit snugly against vessel walls, even in eccentrically shaped vessels. This reduces the risk of embolisation by preventing particles from migrating through gaps and into the blood stream.

Another key feature of the device is its steerability and guidewirelike torque response, which measures the number of revolutions needed to turn the tip 180 degrees within the sheath. Bench testing shows the Defender filter to have improved torque response.

“Torque response is a key attribute for a filter, and Defender performed very well, with a 1to1 torque response between the proximal and distal tip of the wire,” said Dr Dierk Scheinert, director of the ParkHospital Leipzig and head of the Department of Angiology at the University of Leipzig Heart Center. “We were impressed with the trackability of the system. One of the cases had a long lesion (2cm) to cross, and the filter went through without any issue.”
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