A Medical Device Daily

Abbott Diabetes Care (Alameda, California) last week reported receiving CE-mark approval for the FreeStyle Navigator continuous glucose monitoring system for those with diabetes. The system is indicated for adults with diabetes, age 18 and older.

Designed to discreetly measure glucose levels once a minute without the recurring pain and hassle that can accompany conventional blood glucose testing via fingerstick, the system includes a sensor, transmitter and receiver.

The sensor, worn for five days and then replaced, is placed just under the skin and is attached to a plastic sensor mount with adhesive to adhere to the skin, like a patch. The transmitter snaps into the sensor mount and sends glucose information wirelessly to the pager-sized receiver.

The system measures glucose levels once a minute; provides high/low glucose alarms based on customizable, physician- and patient-determined levels; and delivers early-warning alarms that indicate if glucose levels are likely to be too high or too low 10, 20 or 30 minutes in advance. It also stores up to 60 days’ worth of glucose information that can be analyzed by the user or a healthcare professional.

For those with diabetes, less time spent in either a hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) state has been correlated with better diabetes management and reduced risk for a number of serious short- and long-term diabetes-related complications.

“Early feedback about Abbott’s new continuous glucose monitoring system is very promising,” said Thomas Danne, MD, PhD, professor at Bult Diabetes Center (Hanover, Germany). “This new system ... has significant potential to meet the critical needs of diabetes patients by giving them early warnings for highs and lows along with frequent information about their glucose levels.”

“The FreeStyle Navigator System provides people with diabetes with a tremendous amount of new information that is designed to help them act in advance rather than react — this represents an important new advance in diabetes management,” said Chip Hance, senior vice president for diabetes care operations at Abbott.

The company said the accuracy, safety and efficacy of the FreeStyle Navigator system has been demonstrated in two separate pivotal clinical trials, including a five-day in-clinic study and a study of people with Type 1 and Type 2 diabetes at home.

Commercial launch for Ablation Frontiers

Ablation Frontiers (Carlsbad, California), a developer of 3-D catheters for the treatment of atrial fibrillation (AF), said it has commercially launched its Cardiac Ablation System in Europe.

The company received the CE mark for the system, which consists of a portfolio of anatomical based catheters and a radio frequency (RF) energy delivery system, last December, with the first commercial use in Europe taking place in mid-January.

Ablation Frontiers said it has initiated the commercial launch of its products with key international cardiac centers throughout the European Union and in other international markets that recognize the CE mark.

Its catheters are designed to treat all types of atrial fibrillation, including patients with paroxysmal, persistent and the more difficult to treat, permanent AF. They treat tissue in the right and/or left atrium through percutaneous access to the heart.

Powered by what the company refers to as “a cleverly designed RF energy source that allows a physician to precisely control the energy and tailor treatment for the individual needs of the patient,” the system’s design goals “are centered on the need to develop a simple solution that could greatly reduce procedure times, improve safety and be easily learned by most electrophysiologists.”

Ablation Frontiers said that, unlike other treatment approaches, “This technology does not rely on expensive 3-D mapping or complex catheter steering robotics.” The cardiac catheters are inserted through a patient’s leg vein and advanced into the right and/or left atrium. Each catheter is designed to map, and using radio frequency energy, ablate specific target sites through simultaneous selective combinations of multiple electrode channels.

The company said the catheter designs result in increased accuracy for the physician due to the stabilizing nature of the 3-D catheters and the multi-array of electrodes on each catheter. It said its system “allows physicians to tailor the ablation therapy to suit the needs of each patient in as much as half the time as a conventional point to point catheter ablation procedure.” Traditional AF ablation procedures currently take up to four hours or longer to perform.

“It is exciting to be at the forefront of a new technology that can greatly simplify the treatment of atrial fibrillation and result in more patients receiving advanced treatment,” said Ablation Frontiers CEO Keegan Harper.

“This is clearly a therapy designed by electrophysiologists for electrophysiologists,” said Stephen Furniss, MD, consultant cardiologist and senior lecturer at Freeman Hospital (Newcastle upon Tyne, UK). “I have been using these catheters on patients with all types of atrial fibrillation, from paroxysmal to the most challenging of longstanding persistent AF [and] have achieved excellent early results and outcomes as well as substantially reduced my procedure times.”

bioMérieux may close Dutch facility

bioMérieux (Paris) reported that it is studying the feasibility of gradually closing its manufacturing site in Boxtel, the Netherlands. The facility, which has 316 employees, develops and manufactures reagents for molecular biology and immunoassay microplate product lines.

bioMérieux said the Boxtel site already was unprofitable when it was acquired from Organon Teknika, part of Akzo Nobel (Oss, the Netherlands) in 2001. Since then, it has never shown a profit and its operating losses total more than 120 million over the past three years.

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