• Advanced Neuromodulation Systems (Dallas) reported FDA approval to market its second rechargeable implantable pulse generator (IPG), the Eon Neurostimulation System. "With approval for our new Eon system now in hand, we will begin to manufacture product to support a limited launch late in the second quarter and a full market launch in the second half of 2005," said President and CEO Chris Chavez, adding that the FDA approval came earlier than expected. The system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs. "Compatible with all ANS percutaneous and surgical (laminectomy) leads, the Eon system features constant current stimulation delivery and a high-capacity rechargeable battery," Chavez said. He said the Eon system "offers the longest projected usage time between battery charges and the fastest recharge rate of any rechargeable IPG on the market, for greater patient convenience. It also features impressive programming ranges for pulse width and frequency." The Eon system can power up to 16 electrodes in a dual eight-electrode lead configuration.
• Varian Medical Systems (Palo Alto, California) said it has received FDA 510(k) clearance for a brachytherapy solution that enables more accurate and more flexible treatment of nasopharyngeal cancer. The new Varian Nasopharynx Applicator Set has been designed for the delivery of localized radiation therapy in the upper throat area. "This applicator offers an accurate and flexible way of achieving higher doses to nasopharyngeal tumors while delivering minimal dose to adjacent critical structures such as the brain stem," said William Hyatt, vice president of oncology systems operations and head of Varian's BrachyTherapy business. Suitable for use in the nasopharyngeal and oropharyngeal regions, the new applicator set is computed tomography and MRI compatible and will typically be used in combination with external beam radiotherapy. The set comprises two soft and transparent plastic ear, nose and throat mold probes with two soft guidance tubes that can be fed through the nasal cavity without damaging the mucous membranes. It also features an expandable balloon for easy fixation regardless of variations in the patient's anatomy. "It's the only dual channel device of its type to incorporate an expandable balloon for optimal fixation and source placement," Hyatt added.