A sampling of regulatory approvals in Europe in the last month:
• AGA Medical (Plymouth, Minnesota) 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.
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.
• DexCom (San Diego) reported receipt of the CE mark for SEVEN, its seven-day continuous glucose monitoring system.
The SEVEN device is DexCom's second-generation product, designed to help people with diabetes better manage their diabetes and control their glucose levels. Diabetes afflicts an estimated 246 million people worldwide, according to the International Diabetes Federation. Diabetes is a leading cause of adult blindness, end stage kidney failure and lower limb amputations. People suffering from diabetes are also more significantly at risk for cardiovascular disease and stroke.
• diaDexus (South San Francisco, California) received CE Mark approval for the automated format of the PLAC Test for Lp-PLA2. This automated format of the PLAC Test, capable of running on a wide range of clinical chemistry analyzers, received FDA clearance in December 2007.
The company said the PLAC Test is the only blood test cleared by the FDA to assess risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The test measures lipoprotein-associated phospholipase A2 (Lp-PLA2), a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque. It is plaque rupture and thrombosis, not stenosis, that cause the majority of cardiac events. Clinical research demonstrates that early diagnosis of cardiovascular disease improves the likelihood of preventing these events.
• The LifeCell (Branchburg, New Jersey) subsidiary of Kinetic Concepts (KCI; San Antonio) has been granted CE-mark approval by the company's Netherlands-based notified body, KEMA, for its Strattice Reconstructive Tissue Matrix.
Strattice is a porcine-based, acellular dermal matrix that acts as a scaffold that is revascularized and repopulated by the host, ultimately converting the matrix into functional, living tissue.
KCI said the product is recommended for use in a range of applications involving tissue repair to reinforce soft tissue where weakness exists, such as challenging hernia repair and breast reconstruction.
• Ortoviva (Stockholm, Sweden) received CE-mark approval for its Distractor system, which it said "improves and simplifies" the insertion of disc prostheses in the spinal column.
The instruments in the Ortoviva Distractor solution hold and separate the two vertebrae adjacent to a damaged disc.
• Pantec Biosolutions (Ruggell, Liechtenstein) 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.
Pantec says its 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.
• SIRS-Lab (Jena, Germany) received the CE mark for VYOO, a molecular diagnostic test for pathogen detection in sepsis. With VYOO, clinicians can rapidly and reliably identify causative pathogens as well as important antibiotic resistance markers. Therefore VYOO allows for a customized anti-infective therapy in each patient within the critical hours of treatment, the company said.
• Starch Medical (SMI; San Jose, California) reported CE-mark approval of its PerClot Polysaccharide Hemostatic System (PHS) and the StarFoam Absorbable Polysaccharide Hemostat.
PerClot PHS is an absorbable, surgical hemostat composed of Absorbable Modified Polymers (AMP), technology that incorporates plant-based polymer modification processes that yield biocompatible, polysaccharide particles. AMP particles contain no thrombin, collagen, or other human or animal components.
• St. Jude Medical (St. Paul, Minnesota) received 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."