Navigation Links
Xoft Receives Health Canada Regulatory Approval for the Axxent(R) Electronic Brachytherapy System
Date:4/9/2009

Xoft Also Achieves ISO Certification for Quality Manufacture of the Axxent(R) System

SUNNYVALE, Calif., April 9 /PRNewswire/ -- Xoft, Inc., pioneers in the field of micro-miniature X-ray sources for medical treatment, announced today that it has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the Axxent(R) Electronic Brachytherapy System. The proprietary Electronic Brachytherapy (eBx) treatment platform is designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings under the supervision of a radiation oncologist to help reduce recurrence of cancer and improve survival.

Health Canada, the regulatory agency responsible for helping Canadians maintain and improve their health, reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. Commercially available in the United States since 2006 for treatment of early stage breast cancer, endometrial cancer, and skin and surface indications, the Axxent System is also cleared by the U.S. Food & Drug Administration (FDA) for use in the treatment of surface cancers or conditions where radiation therapy is indicated.

Xoft also announced that it has received certification from the International Organization for Standardization (ISO) covering the design, development and manufacture of the Axxent Electronic Brachytherapy System and its components. Xoft has met the requirements of the ISO 13485:2003 standard.

"With this approval from Health Canada, we are proud to make this critical cancer treatment that can be delivered in virtually any standard medical exam room rather than in heavy lead-shielded vaults available to patients outside the United States," said Michael Klein, president and CEO of Xoft. "Combined with recent FDA clearances for new treatment applications, this approval is another significant milestone supporting Xoft's mission of expanding the number of patients who can access radiation therapy and can dramatically benefit from it."

Used to treat cancer for more than 100 years, radiation therapy is administered after breast-sparing surgery to hopefully kill stray cancer cells that might remain in the breast and is proven to reduce the rate of local recurrences and improve long-term survival. As a cancer treatment platform, the Axxent System addresses a variety of oncological and non-oncological indications. The Axxent System delivers non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. Designed to deliver electronic, X-ray-based radiation treatment, the proprietary system can be used in many clinical settings. Treatment can be performed without the need for a shielded room, allowing the radiation oncologist and other medical personnel to be present during treatment delivery and minimizing patient anxiety.

Use of the Axxent eBx System allows physicians to target cancer effectively and expands the ability to provide radiation therapy in remote locations. As a result, tens of thousands of patients will have greater access to therapy that is delivered more easily and conveniently.

About Xoft, Inc.

Xoft, founded in 1998, develops Electronic Brachytherapy (eBx) systems based upon miniaturized X-ray tube technology for the practice of radiation oncology in virtually any clinical setting, eliminating the need for heavily shielded environments. Xoft provides a "point of care model" that is patient centric and accessible to a broader spectrum of patients and their physicians. The Axxent treatment platform provides a therapeutic dose of radiation directly to the region at risk with minimal radiation exposure to surrounding healthy tissue and without the complex handling, resource logistics and costs associated with using radioactive isotopes. Xoft aligns with the Nuclear Regulatory Commission's (NRC) directive to seek alternatives for radioactive medical isotopes. Commercially available for treatment of early stage breast cancer, endometrial, skin and surface indications, the Axxent(R) Electronic Brachytherapy System is also cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated. For more information, visit www.xoftinc.com.

Axxent is a registered trademark of Xoft, Inc.


'/>"/>
SOURCE Xoft, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Core Essence Receives FDA Approval for SECURUS(TM), an Innovative Knotless Suture Anchor System
2. SironaHealth Receives URAC Accreditation as a Health Call Center
3. TRICOR Systems Inc. Receives ISO 13485 Certification; Contract Manufacturer Achieves Another Significant Milestone in 32 Year History
4. Covance Central Laboratory Receives CAP Accreditation in China
5. BioMedical Technology Solutions, Inc. a Division of BioMedical Technology Solutions Holdings, Inc. Symbol (BMTL) OTCBB Receives Frost & Sullivans Product Innovation of the Year Award
6. eDiets.com(R) Receives NASDAQ Notice Regarding Market Value of Listed Securities
7. Hahnemann University Hospital Receives Approval From The Commission on Cancer
8. Berlin Heart Receives First Regulatory Approval in North America
9. Immtech Receives Listing Determination Letter
10. Providences LogistiCare Subsidiary Receives Notice of Award for Five Year Approximately $300 Million New Jersey Statewide Non-Emergency Medical Transportation Contract
11. National All Schedules Prescription Electronic Reporting (NASPER) Bill Receives Preliminary Funding
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... Alpharetta, Georgia (PRWEB) , ... February 11, 2016 ... ... Physicians Group (DMPG) will use the action analytics leader’s population health solutions, ... analytics and clinical support to the Atlanta-area healthcare system. Details of the contract ...
(Date:2/11/2016)... ... February 11, 2016 , ... Dr. Sadati’s ... of cosmetic procedures. Along with performing procedures, the magazine also highlights that Dr. ... cosmetic procedures. One of the most common procedures he performs is his natural ...
(Date:2/11/2016)... ... 2016 , ... Image One USA veteran franchise owner Maria Bogacki ... buildings of Nashville that will benefit. , “I’ve enjoyed being a part of the ... was no question that I would bring my business with me,” Bogacki said. “The ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... to reverse diabetes has been gearing up for their simultaneous grand openings in ... It’s about right now that you’re probably wondering, is reversing diabetes possible? According ...
(Date:2/11/2016)... ... February 11, 2016 , ... In a new paper ... surgeon , Dr. Rod J. Rohrich, and colleagues, examine and underscore the importance ... for rhinoplasty surgeons when addressing this vital area. , The upper lateral cartilage ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... 11, 2016  AfterPill.com is reporting that this week,s ... for all women who are at risk of unintended ... year and raises the risks of unprotected sex in ... According to the Guttmacher Institute, there are 43 ... child-bearing age, who have sex without the intention of ...
(Date:2/11/2016)... de fevereiro de 2016  A Proliant Biologicals ... de soroalbumina bovina (BSA -- Bovine Serum ... na Ilha Norte da Nova Zelândia, em Feilding. ... na fábrica da Proliant nos EUA, localizada em ... e instalação dos equipamentos foram feitos de forma ...
(Date:2/11/2016)... MEADOWS , Ill. and INDIANAPOLIS , ... milestone for many young people, but for those with ... Not only do these students juggle class schedules, assignments ... of living with type 1 diabetes. On top of ... first time. Diabetes Scholars Foundation (Foundation) ...
Breaking Medicine Technology: