Cath Lab Digest

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Study shows silver kills MRSA and other antibiotic-resistant infections
  ConvaTec (Skillman, NJ) released new in vitro study results showing that a wound dressing containing ionic silver is able to kill several strains of highly resistant bacteria, commonly referred to as superbugs. The study showed that bacteria found beneath the dressing died within 48 hours. The study results were presented at the 24th Annual Symposium on Advanced Wound Care and Wound Healing Society in Dallas, TX.

  In the study, bacteria samples (including Acetobactor baumannii, Clostridium difficile, community-associated methicillin-resistant Staphylococcus aureus, or extended-spectrum beta lactamase-producing bacteria [ESBL]) were covered with a silver-containing sodium carboxymethyl cellulose wound dressing. The dressing was shown to be effective against emerging pathogens over a 7-day test period, including against re-inoculation. The dressing killed ESBL-producing bacteria and A. baumannii quickly and consistently, with an approximate 100,000-fold reduction of all pathogens within 24 hours. The rate of kill for C. difficile was rapid, with an approximate 100,000-fold reduction of all bacteria after 4 hours. The potency of silver-containing sodium carboxymethyl cellulose wound dressing against CA-MRSA was effective with a 100-fold reduction in bacterial population within 48 hours and no bacteria detected by day 7.

  For more information, visit www.convatec.com.

Fecal incontinence system receives FDA approval
  Oceana Therapeutics (Edison, NJ) announced the US Food and Drug Administration (FDA) has issued an Approvable Letter for Solesta® as a treatment for fecal (bowel) incontinence. The treatment is a biocompatible bulking agent consisting of dextranomer microspheres and stabilized sodium hyaluronate and has been developed as a minimally invasive treatment for fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for anesthesia. The treatment is injected in the deep submucosal layer in the proximal part of the anal canal. Although the exact mechanism of action has not been identified, it is hypothesized that injections may narrow the anal canal, allowing for better sphincter control.

  The FDA has determined that the treatment Premarket Approval Application (PMA) is approvable and subject to certain requirements relative to labeling and manufacturing. The company welcomes the opportunity to work with the FDA to satisfy the agency’s requests for final marketing approval. The company also will carry out a post-approval study to evaluate long-term treatment data.

  For more information, visit www.oceanathera.com.

Nerve stimulation therapy that aids fecal incontinence now FDA-approved
  Medtronic Inc (Minneapolis, MN) received Food and Drug Administration (FDA) approval for InterStim® Therapy for Bowel Control. The therapy, previously available for the treatment of overactive bladder and non-obstructive urinary retention systems, now is also approved for the treatment of chronic fecal incontinence among patients who have failed or are not candidates for more conservative treatments. The minimally invasive therapy is proven to improve or restore bowel control in more than 80% of patients who received the therapy in a multicenter clinical trial. The implantable system uses mild electrical stimulation of the sacral nerves to influence the behavior of the pelvic floor muscles and bowel. As a result, the therapy significantly reduced fecal incontinent episodes for a high percentage of clinical trial patients.

  The therapy is the only bowel control treatment option that allows patients and physicians to determine probable success of the therapy through a test stimulation procedure before committing to long-term therapy.