Terumo Interventional Systems (www.terumois.com) has introduced the AZUR Peripheral HydroCoil Embolization System for the occlusion of blood vessels, vascular malformations and aneurysms. AZUR is the only peripheral platinum coil embolization system with a hydrogel coating that expands when introduced into the bloodstream, delivering greater filling and mechanical occlusion with fewer coils.

The hydrogel coating undergoes limited expansion within three minutes and fully expands within 20 minutes. AZUR delivers nearly five times more filling volume for a 0.018" coil and four times more filling volume for a 0.035" coil when compared to platinum coils of the same size.

AZUR is the only peripheral embolization system to offer a truly detachable system, enabling physicians to detach coils in less than a second and at the push of a button. Offering the capability to withdraw and reposition the coil until the coil is securely placed, the system minimizes the risk of non-target embolization and coil migration.

FDA CLEARANCE

Visual Ultrasound System

Escalon Medical Corp. (www.escalonmed.com) has received clearance from the U.S. Food and Drug Administration (FDA) to market the VascuView™ Visual Ultrasound System for use in assisted vascular access procedures.

VascuView utilizes a tablet PC with software built on the Microsoft® Windows® XP platform. The probe contains the ultrasound circuitry and is connected via USB. The system also includes a large image display and touchscreen, as well as scan operation controls on the probe to allow maintenance of the sterile field. VascuView provides depth visualization to 6 cm with excellent resolution and accuracy and features software tools such as calipers for measuring
vessel size.

VascuView can be mounted on a stand, used on a tabletop at the bedside or placed into a carrying case for field use.

FDA CLEARANCE

Spot Scanning Irradiation Technology

Hitachi America (www.hitachi.us) has obtained FDA clearance for the spot scanning irradiation technology of its PROBEAT® proton beam therapy system for application at the M.D. Anderson Cancer Center in Houston. Hitachi will be the first to commercialize proton beam therapy with spot scanning technology.

PROBEAT originally used double scatterer technology with two scatterers to expand the proton beam to cover an entire tumor profile. While scattering irradiation technology is effective for many types of tumors, limitations exist in treating tumors depending upon the target geometry.

The new spot scanning technology utilizes an unperturbed narrow beam that is smaller than the typical target cross section and regulated so that prescribed dose spots can be positioned very precisely within a tumor volume.

NEW PRODUCT

Multi-lumen Balloon Catheter

SenoRx Inc. (www.senorx.com) has launched the Contura™ multi-lumen balloon (MLB) catheter for delivering brachytherapy to the surgical margins following lumpectomy for breast cancer. Contura is one of a new class of devices designed to reduce radiation treatment time from six to eight weeks to just five days in patients eligible for treatment. Contura uses vacuum suction to remove excess seroma and air, enhancing conformance of irregularly shaped lumpectomy cavity walls to the balloon surface. The result is delivery of precise radiation dosing through multiple radiation source lumens. Contura may be used in patients who are candidates for balloon therapy but are excluded due to the location of the lesion or their breast size.

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