June 24 2001  


 

Veenendaal, The Netherlands (June 14, 2001) - Nucletron BV today announced that the company has completed the enrollment of patients for the randomized phase II of the PARIS (Peripheral Artery Radiation Investigational Study) Clinical Study for the Nucletron® Paris® leg artery radiation catheter.


PARIS is a multicenter study to evaluate the safety and efficacy of vascular radiation using the Nucletron® Paris® catheter in combination with the microSelectron-HDR™ in preventing the recurrence of leg artery narrowing or "restenosis" after balloon dilatation. It is the first FDA-approved study of peripheral vascular radiation. The Nucletron® Paris® system received a CE-mark in 1997 and is marketed in Europe and several other countries.


It has been estimated that world-wide over 250.000 patients per year undergo dilatation of the important femoral or popliteal leg arteries to resolve their leg pain and walking impairment. The procedure is usually successful but restenosis historically occurs within 12 months in 40-60% of the patients, with the highest risk in cases presenting with long narrowed or blocked regions.


The first phase of the PARIS trial concerned 35 patients who were all irradiated. Thirty of these patients were evaluated both angiographically at 6 months and clinically at 12 months, showing a restenosis rate of 13%.


The second phase is a double-blind randomized study at 20 hospitals in the USA and Europe with 300 patients. All of these are now enrolled. Their study follow-up will be 12 months.


Dr. Ron Waksman, director of vascular brachytherapy at the Washington Hospital Center is the principal investigator of the PARIS study. He commented on the completion of the enrollment saying: " Completion of the enrollment of patients into the PARIS study is an important milestone in the introduction of vascular brachytherapy for the treatment of peripheral arteries. With the data obtained from the feasibility studies in the US and Europe we anticipate to report on intravascular radiation as an effective therapy for the treatment of restenosis for SFA disease".


Vascular brachytherapy is performed immediately after balloon dilatation by advancing a wire, with a sealed radioactive source at its end, through a Nucletron® Paris® centering catheter to the site of the dilatation. A typical radiation procedure takes 5 to 10 minutes.


The Nucletron® Paris® catheter has multiple low-pressure balloons designed to promote centering of the radioactive source within the artery. Centering is important for an optimal dose distribution into the vessel wall. The Nucletron® Paris® catheter is manufactured by the Vascular Intervention division of Guidant Corporation in the USA.


Source storage and remote control is performed by the Nucletron microSelectron-HDR™ afterloader. With over 900 systems currently in use worldwide for cancer treatment, the microSelectron-HDR™ is the dominant afterloader product in the radiotherapy market.


Commenting on the progress of the PARIS study, Rudolf L.J. Scholte, general manager of Nucletron BV said: "We are very pleased to see real progress being made in this important study for Peripheral Vascular Brachytherapy.


Nucletron is confident that the Paris catheter will prove to be a unique product with real clinical advantages for patients suffering from leg artery narrowing."


Nucletron BV, 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 a majority of all systems worldwide. 
Nucletron BV is a subsidiary of Delft Instruments, an international group of companies with about 1000 employees and annual sales of some EUR 180 million.