Terumo Introduces New AZUR™ Vascular Plug and PG Pro™ Peripheral Microcatheter Embolization System

Represents the next generation technology for peripheral vascular embolization

SOMERSET, NJ - July 14, 2021 - Terumo Medical Corporation (TMC) has announced today the introduction of its AZUR™ Vascular Plug, the first and only plug compatible with a microcatheter to occlude arteries up to 8mm in diameter. The newest addition to Terumo's robust embolization portfolio is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

"The AZUR™ Vascular Plug represents a balance of properties - stability, accuracy, and reliable occlusion. This technology has unique advantages that truly make it a market first in embolotherapy, in line with Terumo's ongoing efforts to deliver improved clinical outcomes and economic benefits," said Chris Pearson, Executive Vice President, Commercial Operations, Terumo Interventional Systems.

The AZUR™ Vascular Plug comes in sizes to treat arterial anatomy ranging from 2.5mm to 8mm, with a short deployment length for increased precision. Features include a conformable nitinol braid that stays in place, even in tortuous anatomy. It also comes with a polytetrafluoroethylene (ePTFE) and polyethylene terephthalate (PET) inner composite membrane to facilitate mechanical occlusion. Another key element in the Plug's design is its advanced, predictable detachment mechanism that allows for immediate and reliable deployment with the push of a button. Consistent with Terumo's existing Azur coil portfolio, this state-of-the-art detachment mechanism can allow for a full ability to reposition, while making the process much smoother than traditional twist-off detachment mechanisms.

The launch of AZUR™ Vascular Plug is complemented by the introduction of the PG Pro™ Peripheral Microcatheter, which is indicated for the peripheral vasculature for the infusion of diagnostic and therapeutic agents. The PG Pro™ Microcatheter is designed specifically to deliver all three sizes of the Azur™ Vascular Plug. It comes in radial lengths up to 165 centimeters and a 1200 PSI rating for clearer fluoroscopic imaging. Both are currently only available in the United States.

"Together, these next generation technologies allow physicians to treat larger, more difficult vessels through smaller delivery options. It is yet another way Terumo is providing the opportunity for operators to take advantage of the benefits of radial access for increasingly complex procedures, while enhancing therapeutic options in the peripheral vasculature with a microvascular plug. It is a welcome addition to our innovative, best-in-class portfolio," added Michael Martinelli, MD, Chief Medical Officer, Terumo Medical Corporation.

Important Safety Information for AZUR™ Vascular Plug

This device should only be used by physicians who have undergone training in the use of the Azur system for embolization procedures as described by a representative from Terumo or a Terumo-authorized distributor. This device is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Important Safety Information for PG Pro™ Peripheral Microcatheter

The Microcatheter should only be used by physicians who have received appropriate training in interventional techniques. The Microcatheter is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged. Inspect the Microcatheter prior to use. Do not use the device if any damage or irregularities are observed. The Microcatheter should be advanced or manipulated under fluoroscopic guidance. Do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined. Infusion pressure should not exceed 8274 kPa (1200 psi) to avoid potential rupture of the Microcatheter. The Introducer Sheath is not intended for use inside the patient body. Ensure that the Introducer Sheath is removed from the Microcatheter once the distal shaft of the Microcatheter is placed inside the patient body.

About Terumo Medical Corporation

Terumo Medical Corporation (TMC) is a subsidiary of Terumo Corporation, founded in 1972 as the United States expansion of our larger Tokyo-based parent. For nearly 50 years, TMC has continued the Terumo mission of offering the best possible solutions to healthcare providers and the people they serve. TMC provides products and services across four divisions: Terumo Business Edge, which provides healthcare systems with solutions designed to reduce care variation, improve quality metrics, minimize cost and maximize revenue; Terumo Interventional Systems (TIS), which offers solutions for entry site management, embolization and lesion access; Terumo Medical Products (TMP), which provides devices for injection and infusion therapy; and Terumo Pharmaceutical Solutions (TPS), which develops drug delivery devices. For more information, visit www.terumomedical.com.