A Medical Device Daily
Cyberonics (Houston) said that KEMA Medical, its European regulatory Notified Body, has approved the company’s Model 103 and 104 VNS Therapy Generators and its in-house hydrogen peroxide sterilization process for the Model 102/102R Therapy Generators for sale in the European Union (EU) for the approved epilepsy and depression indications.
The company’s VNS Therapy System is approved in the EU for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures or generalized seizures that are refractory to anti-epileptic medications, as well as for the treatment of chronic or recurrent depression in patients who are “in a treatment-resistant or treatment-intolerant major depressive episode.”
The Model 103 is the next generation of single-connector VNS (vagus nerve stimulation) generators for use in new patients and the Model 104 is the next generation of dual-connector VNS generators for use in patients who have elected replacement of their previous dual-connector generator at the end of its battery life.
Cyberonics said both of the new models are “considerably more functional, smaller and lighter than the previous models.”
The Model 103, which has the three- to eight-year battery life of the Model 102 depending on stimulation parameters, but is about 43% smaller and 36% lighter than the Model 102at 16 grams and a total volume of 8 cubic centimeters.
The company said the models 103 and 104 generators would be priced at up to 15% higher than the models 102 and 102R. It said all four models would continue to be available for the foreseeable future.
Cyberonics said it anticipates submitting a PMA supplement for the models 103 and 104 to the FDA within the next six months.
Agfa completes deal for Heartlab
Agfa-Gevaert (Mortsel, Belgium) said Wednesday that it had completed its $132.5 million (EUR 106.5 million) acquisition of U.S. cardiology imaging and information networks manufacturer Heartlab (Westerly, Rhode Island).
Agfa said it expects the deal to be accretive in the first year.
Heartlab’s Encompass networks are installed in more than 250 U.S. cardiovascular care centers.
Agfa and Heartlab have been collaborating since December 2003 as part of a distribution agreement for the Belgian company’s Impax for Cardiology solution, which allows integration of radiology and cardiology, which Agfa described as “the two most image-intensive departments within hospitals.”
Agfa said the acquisition “will expand on other recent acquisitions to strengthen [our] leadership position in imaging technology and healthcare IT.”
Additionally, Agfa said it has acquired the remaining shares of Med2Rad, a leading developer of radiology information systems (RIS) in Italy.
The transaction price for the 70% of Med2Rad shares that Agfa did not already own was $4 million (EUR 3.2 million). Agfa had bought a minority stake in Med2Rad in January 2003.
Agfa has been the exclusive distributor of the Med2Rad RIS since 2000.
Fujitsu terminates Southern region IDX pact
IDX Systems (Burlington, Vermont) said it has agreed with Fujitsu Services to terminate their agreement under which IDX and British Telecom (BT; London) agreed to provide a “common solution” approach to a clinical information system for the Southern Cluster of the UK National Health Service’s (NHS) Connecting for Health program.
Fujitsu had previously agreed to share a common software solution that IDX was developing with BT, the prime contractor for the London Cluster, to be implemented across the Southern and London clusters.
IDX and Fujitsu’s agreement was conditioned upon Fujitsu and the NHS executing a memorandum of understanding in relation to the development of an alternative solution in the Southern Cluster.
IDX will continue to provide the core clinical records software for the London Cluster.
James Crook Jr., CEO of IDX, said, “Fujitsu Services’ decision to withdraw from the ‘common solution’ and to align itself with another provider for the Southern Cluster is disappointing. We believe that, together with our prime contractor BT, we have overcome numerous obstacles in delivering on the national program, which is unprecedented in scale, complexity and schedule, and will ultimately deliver real benefits to patients, caregivers and NHS staff.”
He added: “We believe that IDX Carecast, one of the first products developed to the rigorous national standards, will be a successful solution for the London Cluster. We eagerly anticipate the first installation of the Carecast system in the coming weeks and the rollout of Carecast in London this year.”
Crook said IDX expects to see “a rapid acceleration” of deployments to NHS trusts in the next 12 months.
Under a subcontract to Fujitsu Services, IDX Systems agreed early in 2004 (Medical Device Daily, Jan. 29, 2004) to provide the core clinical information technology application for the delivery of patient care across the Southern region. It had earlier linked up with BT for the London region contract.
EU has questions on stent’s drug compound
Medtronic Vascular (Santa Rosa, California) said that it has received an update regarding the status of its application for CE-mark approval of the company’s Endeavor drug-eluting coronary stent.
The company said it was informed by European regulatory authorities that the device portion of the review has been completed, but that regulatory authorities have issued a few “clarifying questions” about the related drug compound, ABT-578.
Medtronic Vascular said it anticipates CE-mark approval upon the resolution of these remaining regulatory questions. It said the European regulatory authorities did not provide a specific timeline for completing their final review.
“We are encouraged with the collaborative nature of the overall process and the thoroughness of the review by the regulatory agencies to date,” said Scott Ward, president of Medtronic Vascular. “We believe that these few remaining questions can be addressed quickly.”