Nucletron receives FDA 510(k) Clearance for SPOT PRO™, an innovative 3D System for Planning of Seed Implant Prostate Therapy

November 11 2002  

Veenendaal, The Netherlands (November 11, 2002) –Nucletron B.V. announces FDA 510(k) clearance of SPOT PRO™. SPOT PRO ™ offers a break-through treatment approach since it combines full 3-D ultrasound imaging with real-time treatment planning capability, thus capitalizing on the advances in the imaging technology and giving physicians time-saving treatment options.


SPOT PRO™ is a comprehensive planning system for all seed implant techniques, covering all planning aspects, including pre-planning, intra-operative live-planning and post treatment dosimetry. SPOT PRO ™ is based on extensive cooperation with a number of clinical sites in USA and in Europe.  Particular attention to the work-flow during the intra-operative live-planning process has resulted in an easy and fast planning approach.


In the live-plan process, 3-D needle guidance and dosimetric feedback from the actual needle or seed positions can be calculated during the implant procedure. The updated dose plan allows for corrections during the implant, thereby giving clinicians the opportunity to see the effect of the procedure including monitoring of the dose to the urethra and rectum as the implant progresses.


“SPOT PRO™ will have a positive impact on the radiation oncology community by improving the speed and effectiveness of prostate seed treatment,” said Rudolf Scholte, President and CEO of Nucletron. “While in the operating room, clinicians will have the opportunity to match the treatment plan to clinical requirements, thereby providing an optimal treatment result,” Scholte added.


SPOT PRO ™ is available as a stand-alone treatment planning system for all manual seed implant techniques, covering all treatment planning needs ranging from traditional methods through to the most innovative 3-D live-planning process.  SPOT PRO ™ can also be integrated into the Nucletron FIRST System™ (Fully Integrated Real-Time Seed Treatment), the world’s first automated system for seed implant procedures. When utilizing SPOT PRO™ with FIRST™, clinicians will benefit by having needle guidance and plan optimization as an integrated part of seed treatment.



For more information about SPOT PRO or Nucletron, visit the web site at http://www.nucletron.com/.


About Nucletron B.V.:
Nucletron B.V., with headquarters in Veenendaal, The Netherlands, is a worldwide leader in radiotherapy systems and specializes in some of the most innovative products used for cancer treatment. The company has 11 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 1000 employees and annual sales of almost EURO 200 million.