Medical Device Daily Contributing Writers

Concerns over the health and environmental risks of nanotechnology are generating renewed pressures for tougher regulation in the European Union. The European Parliament is currently drafting a report on regulatory aspects of nanomaterials, and its tone indicates strong suspicion.

"The use of nanomaterials and nanotechnologies promises multiple benefits in innumerable applications for consumers, patients and the environment," says a draft document now under discussion in the parliament's committee on the environment, public health and food safety. But it goes on to say, "nanomaterials on the other hand potentially present significant new risks." As the draft remarks, "the current discussion about nanomaterials is characterized by many contradictions or even paradoxes, with disagreement and thus political struggles."

As an example, the draft cites divergent views over the extent of current use. While inventories compiled by respected institutions list more than 800 manufacturer-identified nanotechnology-based consumer products currently on the market, it says "trade associations of the same manufacturers question these figures, on the basis that they are overestimations, without providing any concrete figures themselves."

And "while companies happily use 'nano-claims', as the term 'nano' seems to have a positive marketing effect, they are strictly opposed to objective labeling requirements."

The debate is the latest in a long series of EU reflections on the subject. It follows a 2005 communication on "a European strategy for nanotechnology," a 2006 "action plan on nanosciences and nanotechnologies," and opinions from the scientific committee on emerging and newly identified health risks on risk assessment of nanomaterials and from the scientific committee on consumer products on the safety of nanomaterials in cosmetics.

According to Euro-MP Carl Schlyter, who is piloting the discussion, "Nanotechnology entails new toxicological risks which are vaguely defined and difficult to test, a field in which our knowledge about immune defense response – if it is able to react at all in any given situation – is poor." He adds, "EU scientific committees point to major deficiencies not only in key data, but even in methods of obtaining such data. But many representatives of industry claim that all relevant data are available and that there are no methodological deficiencies."

In his view, a recent document from EU officials on the regulatory aspects of nanomaterials "is seriously undermined by the complete absence of any information about the specific properties of nanomaterials, their actual uses, and potential risks and benefits."

Schlyter also is cautious about patents and deeply concerned about the links with biotechnology. "A broad application of patents to nanomaterials could stifle further innovation," he says, and "the likely convergence of nanotechnology with biotechnology and information technology raises serious ethical questions."

He urges that ethical guidelines "need to be developed in due time to ensure full respect for ethical values in possible future use of nanotechnology converging with biomedical applications."

CE mark for Biotronik's Trignum

Biotronik (Berlin), a company focusing on vascular intervention and cardiac rhythm management, reported receipt of the CE mark and completion of the first cardiac ablation clinical case with its Trignum Flux magnetic irrigated gold tip catheter.

The launch of the Trignum Flux catheter represents an important introduction of unique, new technology for the treatment of Atrial Fibrillation, and represents another solid block in the foundation of the rapidly growing EP business unit that BIOTRONIK is building. The first clinical case was successfully performed by Prof. Dr. Karl-Heinz Kuck, Director of the Cardiologic Center at the Asklepios Klinik (Hamburg, Germany). During this case a patient who presented with a co-morbidity of atrial fibrillation and atrial flutter was successfully mapped and ablated in both atrial chambers of the heart.

The Trignum Flux magnetic irrigated gold tip catheter is a highly flexible ablation device equipped with three magnets at the distal end. Its complementary flexibility combined with the computer-aided magnetic-guided Stereotaxis (St. Louis) Niobe System ensures a precise, stable, sensitive and reproducible catheter positioning. The safety of the device is further enhanced by the catheter's unique irrigated gold tip electrode with high thermal conductivity. This feature prevents thrombus formation, commonly known as blood clotting, during the ablation procedure and could enable safer procedures with better outcomes, the company said.

"Making the safety profile of our irrigated gold tip ablation catheters available for magnetic navigation will result in a significant increase of adoption for this breakthrough technology. More patients with complex cardiac rhythm disorders can be safely treated. AF is a clear strategic focus for Biotronik with ablation being a therapy solution," said Marlou Janssen, Global VP of Marketing & Sales CRM of Biotronik. "We have strengthened our commitment to this technology with the acquisition of Vascomed last year and we are delivering on our commitment with the launch of six new products this year," he added.

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