Nucletron is awarded FDA 510(k) clearance for OncoSmart™ Intracavitary, a breakthrough in pre-operative rectal cancer treatment

April 18 2005  

Veenendaal, The Netherlands,  –  Nucletron B.V., a global leader providing some of the world’s most innovative products and services for cancer treatment, announced FDA 510(k) clearance for the recently launched OncoSmart™ intracavitary applicator set worldwide.


OncoSmart™ intracavitary applicators treat endorectal cancer, which affects 100,000 patients annually worldwide. The applicator mold improves patient care by reducing overall treatment time, enhancing patient quality of life, and offers significant clinical advantages for treatment management and delivery.


Pre-operative brachytherapy can reduce traditional treatment time by five to seven weeks, benefiting patients with fewer visits to care centers. For patients, the pre-operative brachytherapy treatment can enhance quality of life compared to traditional treatment methods, due to the reduced likelihood of damaging the sphincter, or having a stoma, and it carries fewer side effects. Furthermore, the streamlined treatment offered by the OncoSmart™ intracavitary applicator, enables clinicians to deliver faster care to more patients.


OncoSmart™ Intracavitary has been developed in close cooperation with Dr. T. Vuong, of the McGill University Health Center in Montreal, Canada, and Dr. A. Sun Myint of Clatterbrige Center for Oncology (CCO), Wirral, UK.


“The introduction of the OncoSmart intracavitary is major exciting news for the GI (gastrointestinal) radiation oncologists, and Nucletron is to be congratulated for their excellent support to clinicians and patients needs,” says Dr. Vuong. “This applicator has multiple advantages for clinicians treating patients with rectal cancer as compared to past available rectal probes. It will allow the development of clinical trials of a new treatment modality in the growing field of rectal cancer either as an alternative down staging to chemotherapy and external beam radiation, or as a boost in non-operable patients or as a palliative treatment. I am very impressed with the high tumor down staging and the low local recurrence rate in the first 100 patients treated.”


Dr. Vuong continues, “The applicator was developed under a collaborative effort with Dr Sun Myint of the Clatterbrige Center for Oncology in the UK and Nucletron in order to be practical in fulfilling the clinical needs.”


The OncoSmart™ intracavitary applicators ensure optimal coverage of the target volume for treatment, while sparing the surrounding healthy tissue, using radial-spaced catheters just under the surface of the cylinder. The applicators are CT and MR compatible, with excellent isodose conformity, and are offered as a disposable solution.


Dr A. Sun Myint of Clatterbrige Center for Oncology (CCO), Wirral, UK states: “We developed a new technique using HDR brachytherapy as a contact boost to treat bulky residual tumours prior to local excision using trans-anal micro surgical technique (TEM).
"We have used this new applicator on five of our patients so far. The new applicator is much more flexible, smaller in diameter, longer in length and the material used is much softer. Therefore, the new applicator is much more comfortable for the patient and can treat tumours located much higher compared to other applicators.”  


Dr. Sun Myint continues, “We are in the process of finalizing the protocol on treatment of rectal cancer with the aim to improve sphincter preservation. This will definitely contribute to further improve quality of life of the patient.”


Nucletron continuously seeks to deliver innovations which improve patient care, with dedication to customers. With this groundbreaking solution, Nucletron empowers physicians and physicists to create care that optimally benefits the patient.



About Nucletron B.V.

Nucletron is a global leader in the development, manufacture, sales, service and support of the world’s most innovative products for cancer treatment, with particular expertise in treatment planning systems, brachytherapy, simulation, integrated software solutions for oncology, and comprehensive support and professional education and services. The company has over 20 offices worldwide, including its corporate headquarters in Veenendaal, the Netherlands. For more information on Nucletron, please visit: http://www.nucletron.com/.


Nucletron B.V. is a subsidiary of Delft Instruments. Delft Instruments is the holding company of an international group of companies, which hold a leading position in their respective markets with high quality, high technology products and services. Delft Instruments employs approximately 1,200 people and reported net profit of EUR 10.4 million on turnover of EUR 237 million in 2003. For more information on Delft Instruments, please visit: http://www.delftinstruments.com/. 

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