A Medical Device Daily
ATS Medical (Minneapolis), a provider of cardiac surgery products and services, reported that it has received ISO certification for its quality systems to manufacture and CE-mark approval to distribute its CryoMaze cardiac ablation products in the European Union.
These approvals, in combination with the completion of transfer of the U.S. 510k rights and validation of the manufacturing processes, enable the company to sell the ATS product line in both the U.S. and Europe.
ATS said the regulatory approvals are the final step in the integration of the surgical ablation business, which the company acquired in June 2007. Since the acquisition, ATS has purchased devices from the previous manufacturer to support worldwide sales. In anticipation of these approvals, the company began ramping up its manufacturing efforts in the second quarter and said it believes its current manufacturing capacity is sufficient to meet demand.
"We are elated by the achievements of our manufacturing and regulatory teams in obtaining these key certifications, enabling us to supply both U.S. and European markets with devices manufactured by ATS Medical," said President/CEO Michael Dale. "We are extremely pleased with the market's acceptance of our ATS CryoMaze products and believe this business will be a primary contributor to the acceleration of revenue growth over the next several years."
He added, "With the integration process behind us, we are now able to focus our efforts on manufacturing process improvements and cost reductions and have the flexibility to develop new products on a reduced timeline."
More than 150,000 ATS Open Pivot Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide.
The ATS 3f brand encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less-invasive valve replacement technology.
ATS said its focus on the cardiac surgery segment is further strengthened by offerings that include ATS Simulus annuloplasty products for heart valve repair and ATS CryoMaze surgical ablation products.
Russian medical expo set for December
Zdravookhraneniye 2008, the 18th International Exhibition of Health Care, Medical Engineering and Pharmaceuticals, is scheduled for Dec. 8-12 in Moscow's Expocentr. The event is jointly organized by Messe Düsseldorf, organizer of the annual MEDICA exposition held in Düsseldorf, Germany, and Expocentr.
Russia's largest trade show for medical goods and services, Zdravookhraneniye features exhibits in medical instrumentation, equipment and diagnostics, laboratory instruments, rehabilitation equipment, dental equipment, pharmaceutical production equipment, hospital furnishings and others.
The organizers say Zdravookhraneniye "reflects the growing demand of Russian consumers of high-quality medical care and pharmaceuticals." At last year's expo, more than 1,000 exhibitors from 39 countries presented the latest products and technologies to more than 20,000 attendees from Russia and neighboring countries.
Further information on visiting or exhibiting at Zdravookhraneniye 2008, is available from Messe Düsseldorf in Germany or Messe Düsseldorf North America in Chicago.
Bruker buying surface imaging firm
Bruker AXS (Karlsruhe, Germany) reported that it has signed an agreement to acquire all of the equity of Surface Imaging Systems (S.I.S.; Herzogenrath, Germany), a company with annual revenues of about $3 million. The transaction is expected to close in 3Q08, and no further financial details were provided.
S.I.S. develops advanced atomic force/scanning probe microscopy systems (AFM/SPM) for numerous applications in materials research, including semiconductors, data storage, electronic materials, solar cells, polymers and catalysts.
AFM/SPM is a well-established method for ultra-high spatial resolution surface imaging and the characterization of surfaces down to atomic dimensions. The global SPM market had an estimated total market size of $200 million to $300 million in 2007.
S.I.S. offers a product range from bench-top high-performance AFM-only microscopes to integrated high-end AFM/optical microscopy (OM) combinations, all the way to large floor-standing AFM/OM combination instruments for the characterization of 300 mm wafers in a clean room environment.
The company's core technology includes extremely compact AFM/SPM subunits which can be integrated easily with other analytical instruments such as optical microscopes, Raman microscopes or micro-hardness testers.
"Many of the AFM/SPM market segments and applications overlap with those of our X-ray diffraction (XRD) business, making the S.I.S. products an excellent addition for our established worldwide XRD sales force," said Dr. Frank Burgaezy, executive VP of Bruker AXS. "This clear marketing and distribution synergy is expected to be a major driver for the growth of our new Bruker AFM/SPM product line."