October 19 2003  


 

VEENENDAAL, THE NETHERLANDS – October 19, 2003 – Nucletron B.V., one of the world’s leading providers of life-saving radiotherapy equipment and information software, announces the FDA 510(K) clearance and world wide release of the COMFORT™ Catheter System (patent pending) for interstitial High Dose Rate (HDR) and Pulsed Dose Rate (PDR) brachytherapy cancer treatments. The innovative and patient friendly COMFORT Catheter System offers benefits to both the patient and physician.  The patients are truly more comfortable during the course of treatment since the smooth rounded catheter buttons and unique catheter design enable them to be treated on an outpatient basis, to wear normal clothing, and to resume typical activities with minimal interference.  The COMFORT Catheters also provide ease of use and improved safety for physicians and institutions.  Channel numbers are marked on the catheter buttons and treatment needle assemblies for quick, accurate and easy connection to the Nucletron microSelectron afterloaders.  The unique design enables the ability to remove the treatment needle assembly in between patient treatments, reduces the chance of catheter kinking, and provides a safer closed-end transport channel for the treatment source. This allows for added safety and time-saving opportunities during patient setup that can result in increases in patient throughput and comfort.



The development of the COMFORT Catheter System was in close cooperation with Dr. Luis Linares of New Orleans Cancer Institute at Memorial Medical Center in New Orleans, LA, USA and Dr. Vratislav Strnad of the University of Erlangen-Nürenberg, Germany.  According to Dr. Linares, “the COMFORT Catheter System’s unique design for fixation of the buttons to the catheters and insertion of the treatment needles is very easy and convenient to use. There is no doubt that the COMFORT Catheters are significantly more comfortable for outpatient treatment and easier to take care of than previously available standard catheters.”



“The COMFORT Catheter System is the final piece of the Inergy™ Breast Brachytherapy solution, an Image Guided Radiation Therapy (IGRT) technique developed by Nucletron in collaboration with its clinical partners, emphasizes Jack Coats, President of Nucletron Corporation.  The Inergy system consists of the Kuske Breast Template, and the Insight™ 3-D breast treatment planning module, as well as the COMFORT Catheter System.  With the introduction of the full Inergy system, women will be able to take full advantage of Nucletron’s Accelerated Partial Breast Irradiation solution that will allow radiation therapy treatments to be performed in 5 days rather than 5-7 weeks for external beam treatments.”



Rudolf Scholte, C.E.O. of Nucletron B.V. asserts that the Inergy system with the new COMFORT Catheters demonstrates Nucletron’s strength as a world leader in Brachytherapy and its dedication to innovation and customer intimacy. With this groundbreaking solution, Nucletron clearly helps doctors and physicists to create the best care with the least patient burden. It is important to note that the Inergy system and the COMFORT Catheters have been developed in close cooperation with and by specific requests from leading clinicians.”




CONTACTS:

Mark Adam  
V.P. Marketing
Nucletron BV
The Netherlands
phone + 31 318 557 149
fax + 31 318 557 199
mam@nucletron.nl		 Paula Waddell
Marketing Manager
Nucletron Corporation
USA
phone  410-312-4142
fax  410-312-4126
waddell@nucusa.com
 



About Nucletron B.V.


Nucletron specializes in the development, manufacture, sales, service and support of the world’s most innovative products for cancer treatment and information management.  It is already acknowledged as a well-respected oncology partner by its loyal customer base.


As a company, Nucletron’s guiding principle is the customer’s demand for quality, safety and reliability. It is committed to continuous innovative research and development, consistently reinvesting a set proportion of its turnover.


This forward-thinking approach has made it possible to successfully treat cancers at many body sites, including the prostate, breast, cervix, ovary, bladder, brain, head and neck, lung, and esophagus. Nucletron is proud that curative or palliative (pain relieving) treatment using its products helps to improve the quality of so many patients’ lives.


The company has 20 offices worldwide, including its corporate headquarters in The Netherlands. Nucletron is the world leader in remote afterloading brachytherapy, supplying the majority of all systems worldwide.


Nucletron B.V. is a subsidiary of Delft Instruments N.V., http://www.delftinstruments.com/, an international group of companies with some 1,200 employees, which is listed on Euronext Amsterdam and is included in the NextEconomy segment. Delft Instruments N.V. reported net profit of Euro 10,9 million on turnover of Euro 194 million in 2002.


For more information on Nucletron, please visit http://www.nucletron.com./.



About Memorial Medical Center, New Orleans


Memorial Medical Center, a Tenet Hospital, has 562 beds at two campus locations in New Orleans - the Mercy Campus in Mid-City and the Baptist Campus in Uptown.


The New Orleans Cancer Institute, under the leadership of Luis Linares, MD, is a comprehensive community cancer center accredited by the American College of Surgeons. The Institute specializes in providing oncology services to patients with breast cancer, prostate cancer, colon cancer and bone marrow transplantation.  


Tenet Healthcare Corporation is the nation’s second-largest investor-owned hospital company, with a proven record of developing successful integrated delivery networks.  Tenet, through its subsidiaries, owns or operates 112 acute care hospitals with 27,474 beds and numerous related businesses in 16 states. Tenet and its subsidiaries employ approximately 113,526 people across the country. Tenet Healthcare Corporation is headquartered in Santa Barbara, Calif. Tenet hospitals are supported by a Dallas-based service center. In fiscal 2002, Tenet hospitals nationwide reported 1 million admissions and 9.3 million outpatient visits.


For more information on Memorial Medical Center or Tenet Healthcare Corporation, please visit http://www.memmedctr.com/ or http://www.tenethealth.com/.