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October 31st to November 6th

October 30th: Toshiba Receives FDA Approval for Injector Synchronization Option

Toshiba America Medical Systems, Inc. announced today it received Food and Drug Administration (FDA) clearance for a new CAN Level 1 injector synchronization option for its Aquilion(TM) 64- and 32-slice computed tomography (CT) systems. The new option facilitates contrast enhanced CT exams by interfacing the CT scanner to a contrast injection system - giving clinicians the option to activate the contrast and the scanner without leaving the patient's side.

According to Doug Ryan, senior director, CT Business Unit, Toshiba, the new injector protocol gives clinicians the flexibility they need to deliver better patient care while improving productivity. "Patient comfort and efficiency are primary concerns for clinicians, particularly when it comes to diagnostic imaging procedures that can be stressful for patients," said Ryan. "This new option lets clinicians stay close to the patient while starting the system, limits the number of times a technologist has to leave the room and reduces the time required for each scan."

The new injector protocol will be available on all Aquilion CT systems equipped with Toshiba's Version 3.0 software and is field upgradeable. Version 3.0 software supports synchronization of the injector and CT system using the Level 1 scan protocol option.

About Toshiba America Medical Systems

With headquarters in Tustin, Calif., Toshiba America Medical Systems markets, sells, distributes and services diagnostic imaging systems, and coordinates clinical diagnostic imaging research for all modalities in the United States.

October 31st: Cook Incorporated Receives FDA Approval for Breakthrough Endovascular Graft

Cook Incorporated has received approval from the U.S. Food and Drug Administration (FDA) for its new 36mm Zenith FLEX AAA Endovascular Graft for the treatment of abdominal aortic aneurysms (AAA), company officials report. The state-of-the-art aortic endograft is designed to provide an effective, minimally invasive treatment option for patients with large abdominal aortic neck diameters who previously may not have been candidates for endovascular aortic repair (EVAR).

AAA, a life-threatening disease occurs when a section of the abdominal aorta, the body's main circulatory vessel, weakens and bulges outward to form a fragile, balloon-like swelling called an aneurysm. If the aneurysm ruptures, the patient is at high risk of death as a result of internal bleeding.

With FDA clearance of Cook's 36mm Zenith FLEX AAA Endovascular Graft and 22 French H&L-B One-Shot Introduction System with Flexor Sheath and Captor Hemostatic Valve, physicians can offer an endovascular solution for the interventional treatment of AAA in large aortic necks ranging from 29mm to 32mm in diameter. Cook's Zenith AAA endograft is the world's largest-selling device of its kind and currently is in use in the U.S., Canada, Japan, the European Union, Australia, Latin America and other major markets.

Cook continues to experience tremendous growth and demand for its Zenith product family. The company has seen its market share increase in the rapidly growing market for AAA endografts. In 2006, more than 19,000 Zenith endografts from Cook have been placed in patients worldwide and more than 1,500 U.S. physicians have received clinical instruction in Cook's industry-unique Zenith physician training program.

The 36mm Zenith FLEX Endovascular Graft with 22 French H&L-B One-Shot Introduction System is available immediately.

November 3rd: Boston Scientific Announces FDA Approval of NexStent(R) Carotid Artery Stenting System

Boston Scientific Corporation (NYSE: BSX ) today announced that the U.S. Food and Drug Administration (FDA) has approved the NexStent® Carotid Stent and Monorail Delivery System for use in patients with carotid artery disease who are at high risk for surgery. The NexStent Carotid Stent is manufactured by EndoTex Interventional Systems, Inc. and has been distributed exclusively by Boston Scientific outside the U.S. since receiving European CE Mark in 2005. The Company said it will acquire EndoTex within 90 days under the terms of the companies' existing agreements. The Company said its FilterWire EZ(TM) Embolic Protection System, which was studied together with the NexStent Carotid Stent in the CABERNET clinical trial, is still pending 510(k) clearance by the FDA.

The NexStent Carotid Stent is a laser-cut, nitinol stent with a rolled sheet design that enables one stent size to adapt to multiple diameters in tapered or non-tapered vessel configurations. Its self-sizing feature is designed to provide adaptability when treating lesions in the carotid arteries, and its closed-cell configuration is designed to increase lesion coverage and provide a smooth inner lumen to help facilitate delivery and retrieval of ancillary devices. The NexStent Carotid Stent provides an effective, low profile option for physicians who want a high degree of flexibility and plaque stabilization.

Boston Scientific offers a full complement of accessories for use with this stenting system, including the Sterling(TM) Monorail® PTA Balloon Dilation Catheter, Thruway(TM) Peripheral Guide Wire, Amplatz Super Stiff(TM) Guide Wire, the Mach 1® Peripheral Guide Catheter, and Imager(TM) II Angiographic Catheter. As part of its commitment to fostering the advancement of interventional procedures for the treatment of vascular disease, Boston Scientific also offers comprehensive training, educational and support services to enhance procedural skills.

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