A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported receipt of CE mark approval for its AnalyST implantable cardioverter defibrillator (ICD) with ST Monitoring, calling it "a revolutionary device that not only provides life-saving therapy for dangerously fast heart rhythms, but also continuously monitors electrical changes between heartbeats (called ST segments) to help physicians monitor disease progression."

The company said this new monitoring capability may give physicians earlier and more accurate insight into cardiac problems and may help reduce patient risks.

The device was introduced this week at the International Symposium on Progress in Clinical Pacing, held in Rome.

The company said AnalyST ICD with ST Monitoring is the industry's first device to continuously monitor specific changes in the heart's electrical system which can indicate conditions such as ischemia. It noted that changes in the ST segment also have been linked to events such as heart attacks.

"Learning about these conditions earlier may lead to more timely diagnosis and therapy for patients, and possibly improve patient prognosis," St. Jude said in a statement.

"The AnalyST ICD is the only implantable device that can provide me with ST segment monitoring reports via high-quality, intracardiac electrograms, as well as additional ST segment diagnostic reports," said Christian Hamm, PhD, of the Kerckhoff Klinik (Bad Nauheim, Germany), who implanted the first AnalyST ICD. "This device provides me with new and valuable information about my patients' ST segments that is otherwise not available and helps me deliver better and more timely care for my patients with arrhythmias and coronary artery disease."

With the device's monitoring diagnostic, small changes in ST segment are "continuously and precisely recorded and plotted," St. Jude said, and then retrieved for the physician to review during patient follow-up visits.

It noted that because many cardiac episodes are transient in nature, continuous ST monitoring is important because it gives physicians more comprehensive ST segment information over time rather than a sporadic, hit-or-miss diagnostic report.

The company added that in the near future, physicians also will be able to monitor patients' ST segment changes via remote transmissions from the St. Jude Medical Merlin@home transmitter, a wireless remote monitoring system in patients' homes, and will receive alerts through the Merlin.net patient care network.

Eric Fain, MD, president of St. Jude's Cardiac Rhythm Management Division, said, "Unlike a diagnostic surface ECG, the AnalyST ICD continuously monitors and reports ST-segment changes over time while the patient goes about their normal daily activities."

CE mark for Amplatzer Cardiac Plug

AGA Medical (Plymouth, Minnesota) reported that it has received CE-mark approval for its Amplatzer Cardiac Plug (ACP), which provides a minimally invasive solution for closing cardiac structures not involving the septal wall. One such use will be for the non-surgical occlusion of the left atrial appendage.

"The ACP is an important addition to the interventional tools we have for structural heart repair. The design and conformability of the device as well as its ease of deliverability will allow us to effectively occlude challenging anatomy such as the left atrial appendage," said Bernhard Meier, MD, professor and chairman of cardiology at University Hospital (Bern, Switzerland). "Scientific data suggests a strong link between atrial fibrillation and formation of thrombus in the left atrial appendage, which can increase the risk of stroke to 5% per year. Physicians have limited options to minimize stroke risk other than anticoagulants, which are often associated with adverse side effects."

Made of flexible braided Nitinol mesh, the ACP is designed to provide occlusion with full cross-sectional coverage. The ACP self-orients to the cardiac wall, covering the hole of the structure to be occluded. It leverages the proven microscrew technology platform used in all AGA Medical devices to provide physicians with simple, controlled and precise delivery. This allows the ACP to be recaptured and repositioned if necessary, ensuring a customized delivery and fit for each patient's unique anatomic structure.

"Receiving CE-mark approval for the ACP is a significant milestone for AGA Medical," said President/CEO John Barr. "This device exemplifies our commitment to making structural heart devices that are clinically relevant, safe and easy to use. With approximately 5% of the population over the age of 65 diagnosed with atrial fibrillation, it is one of the most prevalent conditions in this age group. We believe a very large number of patients will benefit from the availability of the ACP."

AGA Medical said it will immediately begin marketing of the ACP in Europe and plans to support the broad adoption of left atrial appendage occlusion for atrial fibrillation. It also will introduce a physician clinical training program utilizing the latest medical simulation technology.

The company has filed for an Investigational Device Exemption with the FDA for clearance to begin a clinical trial in the U.S. in the first half of 2009.

Founded in 1995 by Dr. Kurt Amplatz, a former professor and researcher at the University of Minnesota department of radiology, AGA develops devices for a range of structural heart repair and circulatory conditions. Several of these devices have been innovations in the treatment of common congenital "holes in the heart," such as atrial septal defects and patent foramen ovales.

CE mark, if you P.L.E.A.S.E.

Pantec Biosolutions (Ruggell, Liechtenstein), a privately held company developing transdermal drug delivery technologies, said it has received CE marking for the company's lead product, P.L.E.A.S.E. (Painless Laser Epidermal System), to apply micropores into the human skin prior to transdermal large-molecular-weight drug administration.

"After getting the ISO 13485:2003 certification in September, the CE mark provides us with enormous versatility in our global strategy," said CEO Christof Boehler. "P.L.E.A.S.E. is now cleared for a wide range of transdermal drug delivery opportunities in Europe, and this represents another development milestone we have hit as planned during 2008."

Pantec's P.L.E.A.S.E. platform enables efficient, needle-free and painless administration of biopharmaceutical drugs, in varying and individualized dosages, through partnered patch technology.

The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of $1.5 billion to $2 billion annually.