A Medical Device Daily

Sorin Group (Paris), a device company developing products for the treatment of cardiovascular diseases, reported CE mark certification and market release of the Esprit pacemaker family in Europe. The Esprit pacemaker, the latest family in Sorin Group's pacemaker portfolio, is, according to the company, the world's smallest pacemaker, at 8cc, with no compromise on longevity.

Featuring a set of algorithms designed to help patient safety and delivering proven pacing therapies, Esprit follows the success of the Reply pacemaker launched in Europe in 2007, with a simplified user interface and SmartCheck for faster follow-ups.

Esprit includes a host of algorithms designed for patient safety: continuous lead impedance measurements to monitor the integrity of the lead, automatic adjustment of atrial and ventricular sensing, and ventricular auto-threshold to automatically adjust pacing output in case of changing thresholds.

Esprit includes Dplus, an automatic AV hysteresis algorithm designed to reduce right ventricular pacing. It also features SmartCheck, a tool designed for simplified device checks, which automates follow up tests at the click of a button.

The first Espirt pacemaker was implanted by Jonas Hörnsten, MD, Cardiology Department, at Karolinska University Hospital (Stockholm, Sweden), site of the world's first pacemaker implant in 1958.

"The small size is impressive and for me that matters. SmartCheck is a very attractive feature and saves a lot of time. I'm very satisfied with Sorin products and support," said H rnsten.

First I-ZIP procedures performed in Europe

I-Therapeutix (Waltham, Massachusetts) reported that Richard Packard and Daniel Calladine, MD, from the Prince Charles Eye Unit, King Edward VII Hospital (Windsor, UK), performed the first ophthalmic surgeries in Europe with the company's CE mark approved I-ZIP adherent ocular bandage. All phacoemulsification cataract surgeries were performed under topical anesthesia by Packard. Patients received a foldable IOL with wound-assisted implantation through a 2.2 mm clear corneal incision. No stromal hydration or sutures were used prior to application of the I-ZIP bandage.

"In a previous clear corneal incision architecture study, we showed that low intra-ocular pressure (IOP) in the immediate postoperative period is associated with incision architectural features that suggest lower structural integrity. All I-ZIP patients had well formed anterior chambers and the incisions were observed with complete coverage of I-ZIP postoperatively," said Packard. Patients were comfortable with normal tearing.

The I-ZIP is a synthetic hydrogel composed of about 90% water that can be applied to cornea, sclera and conjunctiva. The hydrogel bandage is applied as a liquid, which then polymerizes in situ, forming a soft, adherent, protective barrier over the ocular incision. I-ZIP bandage is intended to remain on the ocular surface during the normal reepithelialization process and subsequently slowly sloughs off into the tears. I-Therapeutix is conducting a U.S. multi-center pivotal study for the I-ZIP bandage.

REACH list to be updated every six months

Member states, REACH competent authorities and the European Commission reported that starting August 2009 the REACH Candidate List of Substances of Very High Concern (SVHC) will be updated every six months. Member states' nominations for which substances should join the list will be published in February and August each year.

REACH Article 33 requirements for all suppliers to inform customers whether their products contain any of the substances in concentrations > 0.1% w/w start immediately when a new candidate list of very high concern substances is published. Component suppliers and equipment manufacturers who supply to businesses are required to inform their customers immediately at the point of supply. For products supplied to households, the manufacturer must provide substance declarations within 45 days of request.

According to toxics policy advisor Lisette van Vliet at the Health and Environmental Alliance (HEAL): "The evidence that some chemicals on the market can contribute to chronic conditions, such as allergies, some types of cancer, and reproductive problems, is growing daily. New rights created by the REACH law mean that when consumers ask, companies must inform them, free of charge, which harmful chemicals are in their products. By asking for this information, consumers show they want manufacturers and retailers to use safer alternatives."

Five months after the first Candidate List was published in October 2008, however, most product manufacturers are still struggling to gather the necessary data from their supply chains to meet disclosure requirements for this first set of substances of very high concern. Many EU component suppliers are still unaware that they have a legal obligation to inform their business customers when they supply parts, components and sub-assemblies. Outside Europe supply chain awareness is even lower. Many U.S. manufacturers believe that REACH only applies to manufacturers and importers of chemicals, and trying to gather data for candidate list substances of very high concern from Chinese component and assembly suppliers is proving very challenging.

One of the biggest issues that product manufacturers and component suppliers face is accessing expert knowledge on where these substances of very high concern are found in the supply chain. For example, many manufacturers have focused their attention on flexible PVC as the most likely source of the DEHP and DBP reprotoxic substances in their products. However, DEHP and DBP are also found in nitrile butadiene rubber (NBR), which is commonly used in many household and industrial items. Recent samples of NBR components manufactured in China and Taiwan have found concentrations of DEHP and DBP of up to 20% w/w.

Another project underway at ECHA may lead to much more stringent substance disclosure requirements for products which are imported into Europe. The current REACH guidance states that the 0.1% w/w concentration threshold applies to the article as produced or imported. However, Austria, Belgium, Denmark, France, Germany and Sweden have all refused to accept this interpretation, because it requires less substance disclosure for products which are assembled outside Europe compared to products manufactured in Europe, where there are substance disclosure obligations at every stage in the supply chain.

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