A Medical Device Daily

Toshiba Medical Systems (Tokyo) and TomTec Imaging Systems (Munich, Germany) reported an agreement to deliver new tools for assessing cardiac 4-D data and a collaboration to make them more widely available.

With the recent introduction of Toshiba’s Artida Cardiac 4D Ultrasound System, a variety of new 4-D capabilities were released. TomTec diagnostic workstations will be able to read Artida’s data providing increased customer options for image review and a host of new advanced applications.

“We designed Artida to be the first of a new generation of the cardiac 4D ultrasound systems.” said Hiroyuki Tsujino, general manager, Ultrasound Systems Division at Toshiba. “This is why we developed the smallest and lightest 4-D transducers together with the SmartCore technology to generate precise 4-D images quickly.”

TomTec and Toshiba said their new systems are at the forefront of a new push for clinical applications for cardiac 4-D ultrasound. This push is making offline review and analysis of 4-D data increasingly important. “It may be surprising to many users that there is no standard for 4-D ultrasound data formats,” they said. “This means that while regular ultrasound images are compatible across a very wide range of review stations, 4-D data is not.”

TomTec will expand its workstation products compatibility to analyze Artida 2-D, 3-D and 4-D ultrasound data. Bernhard Mumm, president and CTO, said, “By focusing on clinical workflow we can give our customers fast and reproducible results in the field of cardiac 4-D quantification for a variety of clinical applications such as global left ventricular function quantification, regional LV dyssynchrony measurement, mitral valve assessment as a surgical planning tools as well as right ventricular functional assessment.”

In other agreements:

• Hatch Medical (Duluth, Georgia) and Phase One Medical (Carver, Massachusetts) have entered into an agreement for Hatch Medical to broker Phase One’s device anchoring technology platforms, Fusion and Tissue Clip.

The anchoring platforms use shape memory alloys and proprietary design elements which can be integrated into implantable medical devices improving fixation and security of the implant. Phase One’s systems provide bi-directional migration resistance and are not dependant on radial force for fixation unlike hooks and barbs which are used in many implanted devices today.

The company said it anticipates application of the technology to any implantable medical device relying on fixation to prevent migration such as AAA stent grafts, septal defect and PFO repair products and embolic devices.

Phase One Medical is initially using both technology platforms in development of two removable vena cava filter systems for the prevention of pulmonary embolism resulting from deep vein thrombosis. Both systems are deployed using jugular and femoral access, are non-tilting and are easily removed when clinically warranted. Both filters will have the capability to treat large vena cavas in excess of 35 mm.

For physicians who prefer wire guidance, the Tissue Clip system will use a unique over-the-wire delivery system featuring a .035 inch centering guidewire.

• Ark Diagnostics (Sunnyvale, California) and Roche Diagnostics (Mannheim, Germany) have signed a letter of intent to negotiate a collaboration agreement that would grant Roche distribution and commercialization rights for Ark’s anti-HIV drug monitoring products.

Johnny Valdez, president of Ark Diagnostics, said, “Roche will be immediately selling and distributing our products worldwide.”

Ark’s products are immunoassay reagents for certain classes of anti-HIV drugs such as protease inhibitors and nonnucleoside reverse transcriptase inhibitors used to suppress viral replication. The immunoassay reagents are compatible with most automated clinical chemistry analyzers and measure a patient’s blood level of anti-HIV drug, helping doctors to determine if adequate drug exposure has been achieved at a given dose.

“Monitoring tests for viral load and cell markers have contributed significantly to improving the lives of those infected with HIV; the added benefit of measuring drug level is thought to enhance therapy by assuring patients achieve the effective circulating concentration of drug with the dosage used,” Valdez said.

• Quidel (San Diego, California), a provider of rapid point-of-care diagnostic tests, reported the launch of a pilot program with Hoffmann-La Roche (Roche, Nutley, New Jersey) in the U.S. to develop a comprehensive approach to managing influenza.

The QuickVue Influenza A+B test and Tamiflu, an oral antiviral flu medication, will be used together in select U.S. markets.

The program was scheduled to begin this month.

“Our focus has always been to educate physicians on the signs and symptoms of influenza. The rapid test enables physicians to more accurately diagnose the infected patient, allowing for appropriate decisions about treatment and protection against the flu,” said Michael McGuire, vice president infectious diseases at Roche. “The physician will also be able to recommend prophylaxis to other family members to help protect them from getting the flu. Working with Quidel should help physicians make improved decisions about influenza for their patients and practice.”

Caren Mason, president and CEO of Quidel, said, “The agreement with Roche should allow us to demonstrate what physicians and researchers have been reporting globally, that a rapid test helps to support the appropriate utilization of antivirals, resulting in improved patient care.” n

* Aetna (Hartford, Connecticut) said it has reached agreement with Martha Jefferson Hospital (Charlottesville, Virginia) on a new contract that adds the hospital and its 269 affiliated physicians to the company’s Richmond-area network.

“We’re [pleased] to welcome Martha Jefferson Hospital to the Aetna network,” said Carolyn Harrington, Aetna’s senior network manager for the Richmond market. “And we’re looking forward to offering the people in the Charlottesville area access to our HMO-based products.”

Under the agreement, which took effect Nov. 15, members of Aetna network-based plans will be able to receive covered in-patient and outpatient services, at in-network rates, from Martha Jefferson Hospital.

Martha Jefferson Hospital serves Charlottesville and eight surrounding counties in central Virginia. The facility is licensed for 176 beds, and provides cardiac and vascular care supported by on-site cardiac catheterization labs and a vascular interventional radiology lab.

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