Printer Friendly
The Free Library
5,677,581 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

North American Scientific Presents Low Dose Rate Breast Brachytherapy Treatment and Proposed Patient Shielding Solutions to Nuclear Regulatory Commission Advisory Committee.


CHATSWORTH, Calif. -- Unanimous Advisory Committee Informs Company of No Material Concerns of Radiation Risk to Patient or General Public

North American North American

named after North America.


North American blastomycosis
see North American blastomycosis.

North American cattle tick
see boophilusannulatus.
 Scientific, Inc. (Nasdaq:NASI (1) (NetWare Asynchronous Service Interface) A protocol from Novell for connecting to modems in a communications server. It was derived from the NCSI protocol. NASI provides more advanced features than the common int 14 (interrupt 14) method. ) announced today that the Advisory Committee on the Medical Uses of Isotopes (ACMUI ACMUI Advisory Committee on Medical Uses of Isotopes ) to the U.S. Nuclear Regulatory Commission Nuclear Regulatory Commission (NRC), an independent U.S. government commission, created by the Energy Reorganization Act of 1974 and charged with licensing and regulating civilian use of nuclear energy to protect the public and the environment.  reviewed the Company's low dose rate radiation breast brachytherapy treatment and unanimously agreed that it did not have a material concern about radiation exposure provided established patient release criteria patient release criteria Ambulatory surgery An objective parameter used to determine whether a Pt can be released from a health care facility after minimally invasive surgery PRC Post-procedural voiding, hemodynamic stability, neurologically intact, oriented, and  are followed by physicians. North American Scientific is completing design of its unique multichannel catheter device that can be easily placed by the physician following a lumpectomy Lumpectomy Definition

A lumpectomy is a type of surgery used to treat breast cancer. It is considered "breast-conserving" surgery because in a lumpectomy, only the malignant tumor and a surrounding margin of normal breast tissue are
 procedure and prior to radiation treatment. The new catheter device is intended to accommodate either high dose rate or low dose rate treatments.

"We felt that it was important to allow the Commission to raise any questions or concerns regarding our low dose rate design and the light shielding that is incorporated into surgical garments which will allow patients to go home during their radiation therapy treatment," said L. Michael Cutrer, President & Chief Executive Officer of North American Scientific. He continued, "While we did not anticipate there being a concern about radiation exposure, the ACMUI's determination confirmed our opinion and represents an important step forward in our breast brachytherapy program and the planned introduction this November." Mr. Cutrer concluded, "The ACMUI determination follows the recent FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 510k Clearance for the low dose rate design and should provide physicians with greater comfort regarding potential regulatory concerns associated with patient release."

The low dose radiation is delivered through a multichannel catheter device that will be placed through a single incision but will offer the unique ability to better conform to the resection cavity allowing for more conformal con·for·mal  
adj.
1. Mathematics Designating or specifying a mapping of a surface or region upon another surface so that all angles between intersecting curves remain unchanged.

2.
 dose distributions during treatment. The low dose rate option may be preferred by physicians and patients who wish to minimize the dose to surrounding tissue and critical structures. Today, accelerated partial breast irradiation is delivered either through multiple catheters placed in the breast or through a balloon catheter balloon catheter
n.
A catheter with an inflatable balloon at its tip, used especially to expand a partially obstructed blood vessel or bodily passage and to measure blood pressure in a blood vessel. Also called balloon-tip catheter.
 with a single lumen. While both procedures have paved the way for this more convenient treatment option both have drawbacks. Neither is being used for low dose rate treatment. The North American Scientific device is being designed to offer flexibility, reliability, dose optimization and convenience to both the patient and the physician. The Company continues to expect to file a 510k application with the FDA this summer to market a similar device for the high dose rate procedure.

About North American Scientific

North American Scientific is a leader in radiation therapy products and services in the fight against cancer. Its innovative products provide physicians with a set of tools for the treatment of various types of cancers. They include radioisotope-based brachytherapy seeds, used primarily in the treatment of prostate cancer, marketed under the trade name Prospera(R); Intensity Modulated Radiation Therapy (IMRT IMRT Intensity-modulated radiation therapy Radiation oncology A format for delivering high-dose RT to regions–eg, nasopharynx, that are surrounded by radiation-sensitive areas; in IMRT, a broad radiation field is divided into hundreds of small pencil beams, ); and Image Guided Radiation Therapy (IGRT IGRT Image Guided Radiation Therapy ). IMRT allows an escalated radiation dose to be delivered to a tumor while limiting exposure and damage to nearby healthy tissue. The Company's principal IMRT products are marketed under the trade names PEACOCK(R) and CORVUS. The Company's IGRT products, BAT(R), BATCAM BATCAM Battlefield Air Targeting Camera Autonomous Micro Air Vehicle (TM) and nTRAK(TM) provide fast and accurate targeting and localization Customizing software and documentation for a particular country. It includes the translation of menus and messages into the native spoken language as well as changes in the user interface to accommodate different alphabets and culture. See internationalization and l10n.  of a treatment volume on a daily basis. Over 500 hospitals and research sites worldwide are equipped with the Company's clinically proven PEACOCK, CORVUS (our proprietary treatment planning software), BAT, BATCAM, and ancillary treatment solutions. Please visit www.nasmedical.com for more information.

About the Advisory Committee on the Medical Uses of Isotopes

The Advisory Committee on the Medical Uses of Isotopes (ACMUI) advises the U.S. Nuclear Regulatory Commission (NRC NRC
abbr.
1. National Research Council

2. Nuclear Regulatory Commission

Noun 1. NRC - an independent federal agency created in 1974 to license and regulate nuclear power plants
) on policy and technical issues that arise in the regulation of the medical uses of radioactive material in diagnosis and therapy. The ACMUI membership includes health care professionals from various disciplines who comment on changes to NRC regulations and guidance; evaluate certain non-routine uses of radioactive material; provide technical assistance in licensing, inspection, and enforcement cases; and bring key issues to the attention of the Commission for appropriate action.

Statements included in this release that are not historical facts may be considered forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company including, but not limited to, the impact of competitive products and pricing, technological changes, changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements, the ability of the Company to successfully directly market and sell its products, uncertainties relating to patent protection and regulatory approval, the stable supply of appropriate isotopes, research and development estimates, market opportunities, risks associated with strategic opportunities or acquisitions the Company may pursue and the risk factors included in the Company's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this news release speak only as of the date of this release, and the Company undertakes no obligation to revise or update any forward-looking statements, whether as a result of new information, future results or otherwise.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:May 8, 2006
Words:861
Previous Article:Fonality PBXtra Fully Interoperable with Cbeyond's BeyondVoice with SIPconnect Service; SMBs Benefit from Business-Grade VoIP Calls, Affordable,...
Next Article:Sky Petroleum Reiterated At ''Speculative Buy/4'' Rating By Investrend Research Affiliate SISM Research, and Maintains Its 12-Month Target Price Of...
Topics:



Related Articles
AREA FIRM GETS FDA APPROVAL ON PROSTATE CANCER THERAPY.(BUSINESS)
Pouring profits into R&D, Biotech firm seeks payoff. (Corporate Focus).
Endovascular brachytherapy for the treatment of renal artery in-stent restenosis using a [beta]-emitting source: a report of five patients.(Case...
North American Scientific Announces FDA Clearance of Low-Dose Breast Brachytherapy Product; Company Plans Launch in November 2006.
Radiation Therapy Company hopes for reversal of fortune.(North American Scientific Inc Corporate Focus)(Company overview)
Radioactive OK.(North American Scientific Inc.)(Brief article)
North American scientific gets OK.(Public Companies)(Brief article)
Twelve Studies Evaluating Cytyc's MammoSite(R) Radiation Therapy System Presented at ASTRO Annual Meeting.
North American Scientific Announces FDA Clearance of its ClearPath(TM) HDR Breast Brachytherapy System.
Breast Cancer Study Update Affirms Success of Intraoperative Electron-Beam Radiation Therapy (IOERT).(Clinical report)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles