A Medical Device Daily

Medtronic (Minneapolis) reported receiving the CE mark and launching in the European market its Defender embolic protection filter for use during minimally invasive procedures in carotid arteries and saphenous vein grafts.

The first uses of the new filter were carried out recently by interventional cardiologists and vascular surgeons in Germany and Spain, the company said.

Made of braided nitinol, a so-called "memory metal" that resumes its original shape upon deployment, the Defender filter has a low profile and a peel-away delivery sheath that enables physicians to maneuver the device easily across lesions to the desired location, according to the company.

When opened, the filter acts as a basket, allowing sufficient blood flow while simultaneously trapping embolic debris that may become dislodged during a stenting procedure. Without this protection, said Medtronic, embolic debris can flow into other portions of blood vessels — which can lead to a stroke.

The company noted that hundreds of thousands of patients, worldwide, undergo cardiovascular procedures to improve blood flow each year, many involving the implantation of stents.

Rob ten Hoedt, VP of the CardioVascular business for Medtronic in Western Europe, said the Defender filter now is available throughout the European Union.

"While designing the Defender filter, we conducted extensive research with physicians to understand their needs and what they felt were the most important qualities in an embolic protection device," ten Hoedt said. "They told us they needed a filter that is easy to use, with excellent deliverability and a low crossing profile to minimize the risk of dislodging debris when they cross a lesion."

He said the Defender is engineered to meet all those needs, "even in patients with challenging and complex anatomies."

Andrej Schmidt, MD, of the department of clinical and interventional angiology at the University of Leipzig Heart Center (Leipzig, Germany), said, "For me, the most important attribute for a filter is its crossing profile, and Defender has one of the lowest profiles available on the market."

The Defender filter has a 2.2 Fr (0.029") crossing profile and an extendable 0.014" stainless steel core wire that is designed for both flexibility and support, said Medtronic. "The device's mesh filter basket design allows the filter to fit snugly against vessel walls, even in eccentrically shaped vessels. This reduces the risk of embolization by preventing particles from migrating through gaps and into the bloodstream."

iChem analyzer gets CE mark

Iris International (Chatsworth, California) said that its iChem Velocity fully automated urine chemistry analyzer has received the CE mark.

"CE-mark certification represents a major milestone for Iris as we proceed with the launch of the iChem VELOCITY automated chemistry system in more than 50 countries in the international marketplace, where we previously were unable to offer a chemistry unit," said C sar Garc a, president/CEO and chairman of the maker of automated in vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide.

He added: "The iChem Velocity ... enhances and rounds out our core urinalysis business. With CE certification and with more than 1,000 of our iQ 200 automated urine microscopy analyzer units shipped outside the U.S., we now can compete as a complete urinalysis player in the international market."

Garcia said the company expects to release the iChem Velocity in the U.S. in January 2009 to gain "full access to the balance of the $400 million global urine chemistry market."

He said the Velocity, when combined with the iQ200, "forms the new iRICELL complete urinalysis workstation, integrating both urine microscopy and chemistry under our proprietary technology platform, offering our distributors and customers a complete and unique bench top urinalysis solution."

Garcia said several iChem Velocity units are being shipped to international distributors during the first quarter, and that the company is building "a strong order backlog for shipment in the second quarter and beyond."

Diagnostic collaboration advances

Acrongenomics (Geneva, Switzerland) reported that it has committed to a joint collaboration contract in partnership with Molecular Vision (London). Molecular Vision said that the latest iteration of its technology is currently being tested as part of the ongoing R&D agreement.

In one step, the fully functional, multi-channel device will be used to simultaneously measure both creatinine and Vitamin C directly from a urine sample. It is anticipated that this device will be presented to an external audience in the near future.

The parties said progress also continues to be made in the detection of myoglobin, a cardiac biomarker. In keeping with the development timelines this assay will be tested with human blood samples in the near future, reaching another milestone in the evolution of this detection technology.

Acrongenomics is a publicly traded company that focuses on investing in and commercializing novel technology platforms concerning the life sciences sector.

Molecular Vision is an Imperial College spin-out company that develops diagnostic devices for use in the doctor's office and in the home. Those devices combine microfluidic chips with organic-semiconductor light-sources and photodetectors to provide what the company characterizes as "lab-quality diagnostic tests in a miniaturized, easy-to-use, disposable format."

ISO certification for Bruker in Germany

Bruker Daltonics (Billerica, Massachusetts) said it has received ISO 13485 certification for its German operations, calling this certification "an important milestone in the development of [our] in vitro diagnostics business, particularly in the fields of clinical proteomics, clinical microbiology and molecular imaging in pathology."

Dr. Wolfgang Pusch, assistant VP of the Bruker Daltonics Clinical Research Systems business, said, "This is an important step forward for the further growth of our business. Our ISO 13485 certification now allows us to further develop several of our clinical research platforms toward IVD-E mark certification and reimbursement."