DS7AP Muscle Locating Stimulator Cleared for Marketing in the USA
We are delighted to announce that the DS7AP Muscle Locating Stimulator, which is used during surgical correction of anorectal malformation in infants has received FDA 510(k) clearance for marketing within the United States of America. Originally developed as a variant of our DS7A stimulator and first supplied to Great Ormond Street Hospital in London, the DS7AP is the perfect replacement device for ageing and no longer available Integra or Radionics PS-1 and PS-2 “Peña Stimulators”.
Employed by paediatric surgeons to locate the musculature required for the reconstructed anus and supplied with disposable or reusable bipolar stimulation probes, the Digitimer DS7AP provides a 0-100mA constant current stimulus, delivered at a fixed 50Hz frequency. The stimulator has a 100V compliance voltage and offers two pulse durations for different strengths of stimulation. The DS7AP can be supplied with an optional footswitch, allowing the surgeon activate stimulation in a hands-free manner when required. This reduces the need for other theatre staff to control the stimulator.
DS7AP Now Used in Over 30 Countries
Now used in more than 30 countries, the Digitimer DS7AP is fast becoming the “gold standard” dedicated device for this type of surgery. The recent 510(k) listing means that the Digitimer DS7AP is unique as the only stimulator currently available which is cleared by the FDA for use in the posterior sagittal anorectoplasty (PSARP) or Peña surgery.
What is Peña Surgery?
More popularly known as Peña surgery, after Alberto Peña MD who first developed the technique in the 1980’s, the surgery revolutionised the treatment and care of children with anorectal malformation. It gave greater surgical accuracy to the re-positioning of the anus, minimized damage to surrounding anatomical structures, lessened post-surgical pain and most importantly improved the final outcome for patients. By 2012, the Cincinnati Children’s Hospital where Prof. Peña established regular use of the technique, confirmed that the PSARP procedure had been carried out on 3,000 of their patients. Prof. Peña has since moved to Colorado Children’s Hospital where as director of the International Center for Colorectal and Urogenital Care, he also provides training for paediatric surgeons wishing to learn the technique. Part of this training involves the hosting of an annual workshop for paediatric surgeons. This year, a representative from Digitimer North America will be attending the workshop and providing Prof. Peña with a DS7AP Muscle Locating Stimulator which will be demonstrated during the training.