A device designed to keep dangerous blood clots from entering a patient's blood stream and possibly causing a stroke, may soon provide atrial fibrillation (AF) patients an alternative to taking problematic blood-thinning drugs.

Atritech (Plymouth, Minnesota) has filed a pre-market approval (PMA) application with FDA for its Watchman Left Atrial Appendage (LAA) closure device. The company said the PMA contains the results of its PROTECT AF trial, which evaluated the Watchman LAA closure device vs. the current standard of care, the drug warfarin, in patients with non-valvular AF at risk of stroke.

"Patients with atrial fibrillation have six times greater risk of stroke and that's really because of the physics of Afib, the upper chambers beat irregularly and very rapidly and blood tends to pool and clot and the clot goes either to the brain or the vascular system," Jim Bullock, president/CEO of Atritech, told Cardiovascular Devices & Drugs.

Usually, AF patients are prescribed warfarin (Coumadin), which has a number of challenges, Bullock said. For one thing, keeping patients in the therapeutic range is tricky, and literature suggests that as much as 50% of the time an AF patient is outside the range either they are not thinning the blood out enough or they are thinning it out too much. Also, because AF patients tend to be older, there is a greater concern that they might fall and have internal bleeding because of the blood-thinning drug.

Bullock said the Watchman device is meant to be a permanent implant in the LAA, which he described as a small flap outside the left atrium that looks like a little thumb. After 45 days, the patient's left atrium heals over and the device isolates the left appendage from the left atrium, Bullock said, because the company believes that is where the clot forms. Thus, the device will essentially lower the patient's risk of stroke by blocking off that area.

Larry Haimovitch, president of Haimovitch Medical Technology Consultants (Mill Valley, California) and a regular contributor to CD&D, said that for some patients Atritech's device would provide an important alternative to Coumadin. "This is a very interesting area. We've never had any device closures for the left atrial appendage," Haimovitch said.

But there are a lot of questions about the device that the company will have to answer for FDA, particularly about how safe it is and how successful it is in stopping strokes, Haimovitch said.

Of course the company is hoping the data from its PROTECT AF study will answer most of those questions. The study began in early 2005 and enrolled 800 patients at 60 centers across the U.S. and Europe. Bullock said the patients in the study who received the Watchman LAA device were taken off the blood thinner to see if the device reduces strokes and cardiovascular events as well as Coumadin.

"The PROTECT AF trial results are highly anticipated to all those who manage patients with atrial fibrillation, the most common sustained cardiac arrhythmia," said Vivek Reddy, MD, director of cardiac electrophysiology at the University of Miami. "We trust the data will support the approval of the Watchman technology, providing clinicians with an additional tool to manage patients with atrial fibrillation."

Bullock said Atritech has enrolled its first patient into the Continued Access Registry at Washington Hospital Center (Washington) under the direction of Professor Horst Sievert and Ron Waksman, MD.

Atritech acquired intellectual property last year from ev3 (Plymouth, Minnesota) covering LAA closure devices. "Having consolidated the relevant intellectual property covering LAA closure technology, completed the PROTECT AF trial and submitted the PMA, we are very well positioned for the next stage of our company," Bullock said.

If the Watchman device is approved, it shouldn't take long for it to be adopted. "Interventional cardiologists are highly adoptive; they pick up new technology very, very quickly," Haimovitch said.

Elsewhere in the product pipeline:

• Atherotech (Birmingham, Alabama) said its VAP cholesterol test is now included in Biophysical Corp.'s newly released health assessment, BiophysicalCheck. This means that the VAP test, with its ability to identify far more areas of risk than the standard lipid panel, will now be available in Biophysical's biomarker-based health assessment. The Biophysical-Check is based on the technology used in the company's test, the Biophysical250. This test has been called "The Ultimate Blood Test" by Scientific American and has been featured on U.S. syndicated talk shows. The VAP test directly measures LDL and has been shown to identify a far greater number of patients with lipid abnormalities than the standard lipid panel (cholesterol and triglyceride test). The test also reports 15 separate components versus four in the standard cholesterol test.

• CardioDynamics (San Diego) said that the company's BioZ Dx now seamlessly integrates with GE Healthcare's Centricity electronic medical record (EMR) system. The company released its latest version of BioZport ICG data management software which includes capabilities to automatically integrate and transfer BioZ ICG data from the BioZ Dx to GE Healthcare's Centricity EMR system. The company said that this is an advancement for its product, as EMR interface and paperless workflow are increasingly becoming necessities to the outpatient physician when making decisions on new medical technologies.

• GE Healthcare (Waukesha, Wisconsin) reported release of a new pre-clinical computed tomography (CT) scanner designed to accelerate research for cardiovascular disease and drug development. The GE eXplore CT 120 scanner uses X-ray-source technology derived from clinical systems, the company saying that it features 100 times the output of previous GE laboratory research imaging systems and enables X-ray exposures fast enough and detailed enough to capture the motion of a beating mouse heart. This thus brings cardiac CT imaging to an animal often used in disease research and drug development. The scanner features industry-standard DICOM compatibility and an optional analysis workstation to assist in image analysis and production of research data, according to the company.

• ICON (Dublin, Ireland) said that its medical imaging division has become the first commercial imaging core laboratory to offer quantitative coronary angiographic (QCA) analysis with an integrated electronic case report form. This new service has been made possible through the integration of QCAPlus, a QCA application from Sanders Data Systems, with an eCRF within ICON Medical Imaging's proprietary Medical Image Review and Analysis (MIRA) system. The integration of QCAPlus adds to the existing visualization, analysis and project management applications currently available through MIRA. The company provides outsourced services to the pharmaceutical, biotechnology and medical device industries.

• ImaCor (Uniondale, New York) reported receiving FDA clearance for its ClariTEE probe and Zura imaging system. The ClariTEE probe is a miniaturized transesophageal echocardiography probe which facilitates episodic monitoring of cardiac function. The ClariTEE is a single-use device that can remain indwelling for up to 72 hours, allowing intensivists and anesthesiologists to periodically assess cardiac preload and left ventricular systolic function over a prolonged period of time. ImaCor makes solutions for monitoring cardiac function in the critical care environment.

• KLS Martin (Jacksonville, Florida) reported the implantation in the 500th patient of the Sternal Talon, an alternative method of closure for midline sternotomies used in many heart procedures, and using rigid orthopedic-style fixation. Originally developed as a reconstructive alternative for patients with sternal instability and non-unions, the Sternal Talon has been used in primary closure for patients undergoing midline sternotomy for coronary artery bypass graft and valvular surgery, KLS said. It said that many of these 500 patients had multiple co-morbidities which may lead to infections that can be fatal. Until recently the cardiothoracic surgeon had few treatment options for these patients, the company said. KLS develops craniomaxillofacial and sternal fixation technologies.

• NewCardio (Santa Clara, California) revealed the results of its third external validation study of QTinno. The study evaluated the accuracy, precision and speed of OTinno, in producing fully automated measurements of drug-induced QT prolongation, a key cardiac safety indicator. Such data is now required by drug regulatory bodies worldwide for all new drugs in development, and at present must be obtained by expensive and time-consuming manual or semi-automated methods. QTinno is a software suite that provides automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. Its key features include full automation with minimal to no human intervention required, improving the productivity, accuracy and precision of clinical trials, the company said. NewCardio said it believes QTinno is equal to the best manual assessments and is able to provide high-quality quantitative data from a broad range of difficult-to-read ECGs. NewCardio is a cardiac diagnostic and services company focused on the development of platform technology to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram.

• The Sorin Group (Arvada, Colorado) has received FDA approval to market the Reply family of dual and single-chamber pacemakers. Reply combines Sorin's new SafeR pacing mode, SafeR technology building on the AAISafeR pacing mode introduced in Europe in September 2003 and in the U.S. in May 2005. AAISafeR switches from AAI to DDD in case of AV block detection, and has been shown, Sorin said, to reduce unnecessary pacing in both sinus node disease and unselected AV block patients. Delivering unnecessary pacing to the right ventricle has been shown to increase the risk of patients developing heart failure and atrial fibrillation. In addition to SafeR, the Reply pacemaker delivers automatic features such as SmartCheck, which lets the user automate follow-up tests and provides comprehensive data reporting and recommendations.

• Terumo Heart (Ann Arbor, Michigan) reported the first implantation of the DuraHeart, a magnetic-levitation (mag-lev) heart-support device. The mag-lev approach, the company said, means that a crucial, constantly revolving part within the hockey puck-sized implanted device never touches the walls of the pumping chamber. To implant the DuraHeart, the surgeon diverts blood flow from the diseased left ventricle of the heart into a titanium tube that leads into the pumping chamber. The magnetically levitating impeller, a flat magnetic disc, acts as a paddlewheel, turning constantly as it is magnetically attracted to the turning motor within the pump housing. This pushes blood into a flexible artificial blood vessel, which is connected to the ascending aorta.