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ISOLV CE mark received

The new amg Aspiration Catheter ISOLV is now CE-approved!

It will become available at the beginning of 2011.

For more information and product features, please visit the "Products" section of our website.
Registered users can now also view and download the product brochure and CE certificate.
 

ISOLV Preview

Coming soon:

The ISOLV Aspiration Catheter

A Preview is now available! Just click on the picture to see more details:

ISOLV Produkt im Karton
 

Development and Production

amg International develops and produces stents according to proprietary stent designs, which conform to the respective European Quality Standards EN ISO 9001:2000 and EN ISO 13485:2003 + AC2007. Part of the company’s strategy is to make products with “added-value”, i.e. products with characteristics which provide the cardiologist distinct advantages in comparison to competitors’ products.

Stents are available in many different designs and constructions. One of the most frequently used forms is the “slotted-tube” stent , a design which is preferred by amg International.
A metal tube made of surgical stainless steel is cut with a precision laser into a fine mesh structure.

After cutting, the basic stent undergoes further processing in order to give it a particularly
high quality and finish. Electro-polishing is used to produce a completely smooth stent surface. Some stents also undergo a second finishing process in which the surface is “sealed” with the help of ion-implantation. This particular process is used to produce the MACplus Inert stent, for example, in ARTHOSInert, one of amg International’s newer generation of stent delivery system with perfect handling for fast and trouble-free direct stenting.

For the future, amg International will continue to invest much time and effort in the development of new technologies and products. The focus over the coming years will continue to be on innovative products in the field of interventional cardiology and radiology, products such as the PicoElite Paclitaxel-Eluting Coronary Stent .

 

Congress Report - EuroPCR 2009

The EuroPCR 2009 was held at The Forum Congress Center in Barcelona for the third consecutive year. Approx. 130 companies exhibited at the trade fair – about 40 less than in 2008 – which once again was accompanied by an extensive scientific program over a 4 day period (May 19-22). The number of attending physicians and auxiliary cardiology staff - which in previous years had reached the 10,000 mark - was perhaps fewer than in the past, but for amg the quality of contacts was higher than in 2008, thanks to the innovations presented by amg.

amg announced the European Regulatory Submission of its next generation of Coronary Drug-Eluting Stents 'ITRIX' (2nd generation DES) using its patented biodegradable drug coating, as well as the new ISTAR PTCA balloon catheter.
Interventional cardiologists are still in search of a device to address some of the limitations of the 1st generation DES technology. The first generation of drug eluting stents (DES), which use bio-stable polymers that stay as a coating on the stent for the life of the implant, are associated with the complication of late stent thrombosis. AMG International GmbH has now produced the first device – ITRIX - with a novel technology where the polymer is absorbed into the body along with the drug it contains, so that only the metallic stent is left behind. This reduces the potential for thrombotic complications.

Working with the guidance of its global medical advisory board of interventional cardiologists, AMG has completed its pivotal study and is now awaiting CE approval to initiate the commercialization of this latest innovation. AMG International expects to launch this technology in late 2009 or 1st half of 2010 through its expanding global network of subsidiaries and distribution partners in Europe and Asia. The ITRIX platform is equipped with a sophisticated polymer which degrades after the release of the drug rapamycin, a well-known, highly efficient drug which prevents restenosis and avoids early thrombotic events post-implantation.
The drug and polymer kinetics chosen ensure optimized absorption of both components by the body and ensure the best possible results. The stent platform that is left is a proprietary technology using the company’s own carbon-ion implantation process to significantly enhance biocompatibility after the drug and the coating have been absorbed. This ‘double protection technology’ used in ITRIX helps minimize patient risk associated with coronary stent implants and avoid late stent thrombosis and restenosis.

For further details about the innovative ITRIX technology, see the full Press Release(please click here for the press release).

The EuroPCR 2009 scientific program was once again packed full of interesting presentations, such as 2nd generation DES, bio-absorbable stents, drug-eluting balloons and self-expandable peripheral stents. All in all, the EuroPCR2009 was considered a success for amg despite overall lower numbers of attendees and fewer exhibitors.

The EuroPCR 2010 will be held once again in Paris.

 

Quality Management - More than just Quality Control


Quality management plays an important role within the medical device industry. Quality does not mean high or low performance, it means reliably consistent products or services.

Quality Assurance Management at amg International is aimed at satisfying customers on a consistent basis. Like all successful companies, we want to gain a sound reputation for reliability, value for money and good customer service. In this way, we can be sure that customers will come back and repeat their purchases. This is a general formula for success, which amg International also follows.

Certification means that companies have been examined and found to have an effective management system, which is capable of consistent performance. This examination is conducted against a published standard known throughout the world as the ISO (International Standard) 9000 series. EN ISO 9001 describes those elements as a set of requirements for any company’s management system. The special requirement for medical devices is covered by the standard EN ISO 13485:2003.

All medical devices have to undergo registration and approval before they can be sold in the European Community. This process is carried out by a Notified Body, such as the DEKRA, which checks that the product specification is in compliance with the Medical Device Directive 93/42/EEC and certifies this by issuing a respective CE certificate.

The European CE certificate is accepted widely throughout the world as an endorsement of product conformity and quality and allows the product to be
marketed.

So, you see at amg Quality Management really does mean more than just Quality Control!


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