Medtronic Japan releases resolute Onyx drug-eluting stent

Medtronic Japan Co., Ltd. (head office, Minato-ku, Tokyo; president, Tony Semedo) will release a drug-eluting stent Resolute OnyxTM Coronary Stent System (hereafter, Resolute Onyx; Medical Device Approval No. 22900BZX00186000; product name, Resolute OnyxTM Coronary Stent System) on July 10th. In addition to its abundant clinical performance, the Resolute Onyx offers superior deliverability to that of its predecessor Resolute IntegrityTM(initial sales in Japan, August 2012).

“With the new Core Wire Technology, the Resolute Onyx aims for improved deliverability in complex lesions, enhanced conformability to the vessel wall and greater radiopacity for more accurate stent placement,” said one of the investigators of the RESOLUTE Japan Study Shigeru Saito, M.D., assistant director of Shonan Kamakura General Hospital/cardiology and catheterization laboratories. “The Resolute Onyx will be one of the new standards of durable polymer drug-eluting stent (DES) in Japan.”

With the Core Wire Technology of Resolute Onyx, a metallically dense, radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. The Core Wire Technology also enables thinner struts while maintaining structural strength to radially support the blood vessel. The Continuous Sinusoid Technology originally used in the Resolute Integrity is a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This enables a continuous range of motion, flexible and superior conformability to the vessel wall, and good stent apposition. The Core Wire Technology is another new technology developed following the Continuous Sinusoid Technology.

■Product Features

1. Core Wire Technology

A metallically dense, radiopaque inner core is incorporated within the cobalt alloy wire to enable thinner struts while maintaining structural strength and enhance deliverability. Visibility is also enhanced for accurate stent placement.

Core Wire Technology: diagram

Shell: cobalt alloy

Core: platinum iridium

2. Continuous Sinusoid Technology

A unique Medtronic method of stent manufacturing, which involves forming a single strand of wire into a stent. This enables a continuous range of motion, flexible and superior conformability to the vessel wall, and good stent apposition.

Continuous Sinusoid Technology

Forming into sinusoid

Wrapping spirally

Laser welding

Continuous range of motion (diagram)

3. Wide range of stent size

In addition to 52 products with the stent diameter of 2.25 mm to 4.0 mm and length of 8 mm to 38 mm, long stents with 2.5- to 2.75-mm diameter (length, 34 mm and 38 mm) are now available. The wide range of stent size offers physicians more treatment options and helps them treat complex lesions.

Resolute OnyxTM Coronary Stent System (product name, Resolute Onyx Coronary Stent System)

Medical Device Approval No. 22900BZX00186000

In collaboration with clinicians, researchers and scientists, Medtronic offers the broad range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

[About drug-elution stent (DES)]

DES is used in percutaneous coronary intervention (PCI), which is a less invasive treatment of ischemic heart disease. DES is placed to widen the narrowed part of coronary artery (a lesion where the blood flow is decreased because of advanced arteriosclerosis) that sends blood to the heart, and elute drug substance in the area to prevent restenosis.

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 88,000 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.

About Medtronic Japan Co., Ltd.

Established in 1975, Medtronic Japan strives to contribute to human welfare through application of bioengineering technology and development of medical devices to alleviate pain, restore health, and extend life in people with chronic diseases. The advanced medical technology of Medtronic plc covers a wide range of chronic diseases such as heart disease, Parkinson’s disease, diabetes mellitus, spinal disease, cerebral disease, and chronic pain.

Web site http://www.medtronic.co.jp

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.