A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported receipt of the CE mark for its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter-defibrillator (ICD).

The company said these devices represent “entirely new platforms to treat heart failure and sudden cardiac death and are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients.”

Boston Sci said the Cognis and Teligen products are designed to eliminate compromises physicians often must make in choosing a high-energy device, including trade-offs among device size, battery longevity and features.

The two new products are among the world’s smallest and thinnest high-energy devices, at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Boston Scientific said both devices offer features based on significant engineering advances, including extended battery longevity, self-correcting software and improved programming technology.

Both devices also offer SafetyCore, a feature that in the unlikely event of a system error provides lifesaving shock therapy and basic pacing functionality, the company said.

Key features of the Cognis CRT-D include SmartDelay, which quickly proposes programmable device settings, enabling physicians to tailor individualized pacing therapy for their patients; Bi-V Trigger, which helps physicians manage heart failure patients with frequent atrial arrhythmias; and Electronic Repositioning, which provides physicians with six configurations for stimulating the left side of the heart even after implant, which may help avoid an additional surgical procedure.

Teligen ICD features include Reverse Mode Switch, designed to eliminate unnecessary ventricular pacing, and Quick Convert, which provides the ability for patients to receive pacing therapy for ventricular tachycardias.

“Our CRM team is refocused on delivering therapy systems that meet clinician needs for safety, reliability and better patient outcomes,” said Jim Tobin, president/CEO of Boston Scientific. “We have re-engineered the way we design, build, test and report on our technology. The Cognis CRT-D and Teligen ICD are testaments to the revitalization of our CRM business and are just two of the many new products we plan to launch in 2008.”

The first Cognis and Teligen implants are scheduled to take place early next month. The company said it plans to build to a full launch in Europe and other international markets in 2Q08.

The two new products have not been FDA-approved.

Scottish firm disputing Verathon patent

Aircraft Medical (Edinburgh, Scotland) said the European Patent Office (EPO) has found Verathon Medical’s (Bothell, Washington) European patent (the ’131 patent) not valid as granted. A narrower version of the patent was upheld in an EPO ruling on Oct. 16, 2007.

Aircraft said that Verathon issued a press statement at that time announcing the EPO ruling as a success, “despite the fact that the ruling severely weakened its patent.”

Verathon has now appealed the EPO’s October 2007 ruling. Aircraft said that appeal “very effectively demonstrates that the EPO decision was in fact not favorable to Verathon.”

Aircraft added that in a re-examination request it has raised, the U.S. Patent and Trademark Office “has so far declared that every claim in Verathon’s issued U.S. patent No. 6,543,447 is invalid.”

Aircraft said it also has taken the opportunity to challenge the validity of Verathon’s European patent, and “has already successfully narrowed it as a result of substantial prior art, and will make further invalidity submissions to the EPO in due course.”

Aircraft is the manufacturer of the McGrath Series 5, which it calls “the world’s first fully portable video laryngoscope.” The company says it is the first video laryngoscope with a guaranteed sterile blade, and the first laryngoscope that can vary in length to suit varying anatomy.

“The McGrath Series 5 has helped keep patients alive in emergency cases where other equipment has failed, and as a result is enjoying significant market uptake,” Aircraft said.

Aircraft said it has signed distribution contracts in North America and several European countries.

FDA licenses French firm’s blood assays

The FDA licensed 14 new tests for determining a person’s blood type, a process termed essential to a safe U.S. blood supply and safe transfusions. The tests are manufactured by Diagast (Loos Cedex, France).

“These 14 new tests will provide blood establishments and transfusion services with additional choices to help assure safe, well-matched transfusions,” said Jesse Goodman, MD, director of FDA’s Center for Biologics Evaluation and Research. “The tests offer a broader diversity of reliable blood-typing tests and will help protect against product shortages.”

Knowing the blood types for blood donors and patients is critical, FDA said. Patients may experience serious, possibly life-threatening reactions from mismatched transfused blood. The most familiar blood types are A, B, O, and Rh.

The Olympus PK System Blood Group and Phenotyping Reagents use monoclonal antibodies to test for the A, B, O, and Rh factors as well as for other factors that signify a rarer blood type.

Benchtop densitometer from Grant

Grant Instruments (Cambridge, UK), a supplier of scientific, life sciences and data acquisition products, said it has expanded its Grant-bio product line with the introduction a compact and efficient benchtop densitometer for measurement of cell suspension turbidity and cell concentration across a wide variety of life science, microbiology and industrial applications.

The Grant-bio DEN-1 densitometer is factory calibrated and able to measure turbidity in the range of 0.3 to 5.0 McFarland units with a small standard deviation. The range can be extended up to 15 McFarland units but with a concomitant increase in the standard deviation.

It also can be user calibrated with commercial standards or cell suspensions prepared in the laboratory. The unit features a light diode at 565nm wavelength and boasts a measurement time of around one second per sample.

Typical applications for the new densitometer include determining the concentration of cells (bacterial and yeast) in fermentation processes, detecting the susceptibility of micro-organisms to antibiotics, identifying micro-organisms with various test systems, and measuring optical density at fixed wavelength.