Medical Device Link.

Originally Published EMDM September 2004

Industry News

Medisize Development & Manufacturing will provide moulding, assembly, packaging, and sterilization services to Nucletron, which markets the Comfort Catheter System.

It has been a very good year indeed for Medisize Development & Manufacturing (Hillegom, Netherlands). The firm recently announced a long-term agreement to supply Nucletron B.V. (Veenendaal, Netherlands) with disposables for its proprietary catheter system. This follows on the heels of an exclusive multiyear agreement with Swiss Medical Care S.A. (SMC; Lausanne, Switzerland). Medisize manufactures all of the disposable parts used in that firm’s contrast-media delivery system.

Medisize collaborated with Nucletron on the design and development of disposables for the Comfort Catheter System for the treatment of cancer. The device is used in brachytherapy, which involves placing a radioactive source inside or near a treatment area. Its patented design includes flexible catheters with smooth rounded buttons that remain in the patient’s body and removable treatment needle assemblies. Channel numbers are marked on the catheter buttons and needle assemblies to allow quick and accurate connections. Approved for use by US FDA in 2003, the device increases patient comfort and clinical productivity, according to Nucletron.

Earlier in the year, Medisize announced the signing of a multiyear supplier agreement with Swiss Medical Care. Under the exclusive contract, Medisize will manufacture all disposables for SMC’s CT Exprés contrast-media delivery system. A winner of the 2004 Medical Design Excellence Awards, the CT Exprés employs a novel approach for the delivery of contrast media in computer tomography. It is reportedly the first and only multidose injector for this application. The CT Exprés enables radiologists to transfer contrast media directly from the manufacturer’s container, thus eliminating the need for syringes.

The device consists of one pump unit, two control panels, and three sterile disposables: a patient set, bottle spike, and day set. The patient set is a peristaltic cassette that is injection moulded and assembled in a cleanroom. The bottle spike connects the contrast-media bottle to the pump, which is connected to the patient set via a day set spike. The partnership with Medisize will ensure delivery of cost-effective disposables to customers worldwide.

Medisize offers contract development, industrialization, and manufacturing services to the medical device, diagnostic, and pharmaceutical industries. Registered with US FDA and certified to ISO 9001 and ISO 13485, Medisize has production sites in the Netherlands, Ireland, and the Czech Republic. The company will exhibit at MEDTEC Ireland, which returns to Galway on 29–30 September.

For more information, contact the firm at Edisonstraat 1, Hillegom NL-2181 AB, Netherlands; phone: +31 252 576888; fax: +31 252 519825; e-mail: sales.dm@medisize.com; Internet: www.medisize.com/dm.   

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