FDA Approvals: Viatorr Endoprosthesis, superDimension/Bronchus, and Others

Yael Waknine

December 21, 2004

Dec. 21, 2004 — The U.S. Food and Drug Administration (FDA) has approved an endoprosthesis for the treatment of portal hypertension and tracheobronchial strictures, a computed tomography–guided system for bronchoscopy, a test for use in diagnosing thromboembolic events, a surgical laser for ablation of soft tissue during cardiac surgery, and a cryoablation probe for the treatment of cardiac arrhythmias.

Endoprosthesis (Viatorr) for TIPS Procedures and Tracheobronchial Strictures

On Dec. 8, the FDA approved an implantable device (Viatorr Endoprosthesis, made by W. L. Gore & Associates, Inc.) for the treatment of portal hypertension in de novo and revision transjugular intrahepatic portosystemic shunt (TIPS) procedures, and for tracheobronchial strictures.

The device features a proprietary reduced permeability expanded polytetrafluoroethylene (ePTFE) graft lining that minimizes transmural permeation of bile and mucin (common causes of patency loss), and reduces tissue ingrowth into the graft for facilitated surgical dissection during liver transplantation. The unlined nitinol "chain-link" portion of the graft allows nutrient portal perfusion.

The endoprosthesis is available in diameters of 8, 10, and 12 mm, and its graft-lined length ranges from 4 to 8 cm. It is delivered over a guidewire diameter of 0.038 inches or less and placed via a 10 Fr introducer sheath. The device is designed to provide secure anchoring with minimal kinking.

CT-Guided Bronchoscopy (superDimension/Bronchus) Allows Access to Peripheral Lung Areas

On Nov. 8, the FDA approved a computed tomography (CT) system (superDimension/Bronchus, made by superDimension, Ltd.) for displaying images of the tracheobronchial tree to aid in the navigation of endoscopic tools in the pulmonary tract.

CT-aided bronchoscopy allows visualization of peripheral lesions and lymph nodes that are beyond the bronchoscope's field of vision. It can be used in a regular bronchoscopy suite with any standard bronchoscope or diagnostic/therapeutic bronchoscopy tool.

According to a company news release, the device may be helpful in the minimally invasive diagnosis and treatment of lung disease, including lung cancer, emphysema, asthma, and tuberculosis.

Clinical trials in Europe and Israel have confirmed successful use of the device in the biopsy of peripheral lung lesions. Additional trials in the field of therapeutics and lymph node aspiration will be conducted next year in the U.S. and Europe.

Fluorescence Diagnostic Immunoassay ( Triage D-Dimer Test) Aids in Diagnosis of Thromboembolic Events

On Nov. 29, the FDA approved a fluorescence diagnostic immunoassay (Triage D-Dimer Test, made by Biosite, Inc.) for use with the Triage Meter Plus in assessing and evaluating patients suspected of experiencing thromboembolic events, including pulmonary embolism. Elevated levels of D-dimer are associated with abnormal rates of intravascular coagulation and fibrinolysis.

The test is portable and may be easily used in the emergency department or at a patient's bedside to measure the amount of cross-linked fibrin degradation products containing D-dimer in samples of whole blood or plasma.

According to a company news release, the test will be available in the U.S. in February 2005.

Laser (Atrilaze Soft Tissue Ablation System) Approved for Use in Cardiac Surgery

On Nov. 30, the FDA approved a soft tissue ablation system (Atrilaze, made by MedicalCV, Inc.) for use during cardiac surgery. The self-contained compact laser system includes a generator and hand-held probe that delivers cardiac tissue–specific 810-nm radiation for the incision, excision, vaporization, ablation, or coagulation of targeted soft tissue.

According to a companynews release, the device will be available in the U.S. in January 2005.

Cryoablation Device (Breva Surgical Probe) for Treatment of Arrhythmias

On Oct. 25, the FDA approved a surgical device (Breva Surgical Probe, made by CryoCor, Inc.) for use by cardiothoracic surgeons in the treatment of arrhythmias through cryoablation of electrically abnormal cardiac and vascular tissue.

The probe interfaces with a console as a new addition to the company's Cardiac Cryoablation System.

Reviewed by Gary D. Vogin, MD

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