A Medical Device Daily

St. Jude Medical (SJM; St. Paul, Minnesota) said it has received the CE mark for its SJM Confirm implantable cardiac monitor (ICM), a compact device designed to detect atrial fibrillation (AF) and other abnormal heart rhythms.

Described by the company as being about the size of a computer thumb drive, the SJM Confirm ICM is the smallest implantable cardiac monitor available. It is implanted subcutaneously in the upper chest region and can be implanted in an outpatient procedure under local anesthesia.

The device, which will be launched in Europe this month, features a sensing algorithm designed to aid in better signal detection, thus enabling physicians to program the monitor to better sense small and wide-ranging signals. Electrodes on the monitor sense cardiac activity and a continuous loop recorder stores information about the heart's activity.

St. Jude said the electrodes are positioned on opposite sides of the device, which is designed to provide better contact with the subcutaneous tissue for more accurate sensing of cardiac signals.

"The SJM Confirm implantable cardiac monitor will help me to accurately detect and record the cardiac rhythm events associated with syncope and other arrhythmias, as these can be difficult to distinguish with other diagnostic methods," said T. Lewalter, MD, of St. Vincenz—Krankenhaus (Paderborn, Germany).

"Many millions of people worldwide suffer from AF, with about one-third experiencing asymptomatic, or 'silent' AF," the company said, while "other patients experience paroxysmal AF [which] starts suddenly and may last a few seconds, minutes or hours before spontaneously stopping."

The company said such patients "represent a particular diagnostic challenge, as they are likely to experience asymptomatic arrhythmia events up to 12 times more frequently than symptomatic arrhythmia events and are often unaware that AF is occurring."

Similarly, said St. Jude, many patients suffer from unexplained syncope, or fainting, "the source of which, according to some physicians, is the hardest diagnosis to make."

Eric Fain, MD, president of St. Jude's Cardiac Rhythm Management Division, said, "This monitor has the ... capability to send stored electrocardiogram data over the telephone line that provides physicians a more continuous view of what's happening with patients between office visits. [It] also allows patients to control the data being recorded at times when they are symptomatic, thereby assisting physicians to have precise heart rhythm monitoring information to aid them in determining the best course of treatment."

St. Jude said the Confirm ICM is the first implantable monitor to be built on a unified platform, which has enabled the company to more quickly introduce devices with new features and diagnostics as they become available because the basic platform for all of the devices is the same. The St. Jude Medical "Unity" device platform was introduced in September 2007 with the launch of the Promote RF CRT-D and Current RF ICD devices.

The Confirm ICM also is compatible with SJM's Merlin Patient Care System, a portable computer designed to help physicians access and analyze diagnostic information and print full-size comprehensive data reports.

deCODE test added by Lab21

Lab21 (Cambridge, UK) reported the addition of deCODE BreastCancer to its molecular diagnostics portfolio, which will be available across the UK and Ireland

deCODE Genetics' (Reykjavik, Iceland) BreastCancer assay can be used to predict a woman's lifetime risk of developing breast cancer, which is compared with the average risk of breast cancer across the population. Using this data, patients at an increased risk can be identified and referred for more extensive testing if the results indicate they are at an increased risk.

Lab 21 said such genetic tests "are rapidly becoming key tools in modern medicine and Lab21 already offers the commonly used analysis of the BRCA1 and BRCA2 genes which can identify those patients at risk of development of early-onset inherited breast cancer."

Dr Berwyn Clarke, chief science and development officer at Lab21, said: "This new test represents a significant step forward in the ability to predict breast cancer risk in the general population and provides physicians with a clearer understanding of the patient's personal risk of developing this disease."

Clarke added, "Not only does it provide vital information on the 95% of breast cancers which result from the interaction of genetic, environmental and lifestyle factors, it can also be used to modulate the risk profile of the early onset inherited forms of breast cancer in women who have tested positive for risk variants in the BRCA1 or BRCA2 genes."

deCODE BreastCancer is a DNA-based reference laboratory test performed using a simple blood sample or cheek swab, ordered by physicians on behalf of their patients. The test measures seven widely replicated single-letter variations (SNPs) in the human genome that deCODE and others have linked to risk of breast cancer. These SNPs contribute to the incidence of an estimated 60%of all breast cancers.

CTLM system set for Hungarian center

Imaging Diagnostic Systems (IDS; Fort Lauderdale, Florida) said that its distributor, Kardia Hungary Kft, has purchased the first CT Laser Mammography (CTLM) system for use in Hungary.

The CTLM system will be installed at the new MeDoc HealthCare Center (MDHC; Budapest), in collaboration with Dr. Maria Gergely, chief radiologist of Uzsoki Hospital.

"I am very excited to have this opportunity to provide my patients with more comprehensive imaging and I hope to find more cancers in the dense breast patients where it is most difficult to image with today's current technologies," Gergely said.

MDHC is a new privately operated medical center that focuses on the latest detection for cancer by offering its patients the most current and cutting edge imaging equipment.

The CTLM system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless and does not expose the patient to ionizing radiation or painful breast compression.

CTLM is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.

No Comments