MEDICAL DEVICE INNOVATION - Medical Device Daily

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12 Applied Medical debuts surgical access in Europe MEDICAL DEVICE INNOVATION 2010 By JOHN BROSKY Medical Device Daily European Editor PARIS — A novel device for single-incision surgery from Applied Medical (Rancho Santa Margarita, California) made its European début at the 111th French Surgery Congress. The GelPOINT, which won 510(k) approval from the FDA in February, goes head-to-head with single-port access (SPA) devices from Covidien (Dublin, Ireland), Olympus (Tokyo) and Karl Storz (Tuttlingen Germany). Yet innovative features of the new Applied Medical port create advantages against these established competitors and challenge other SPA products with its unique surgical approach. The current line of SPA devices target the umbilicus as the point of entry for scar-less surgery, so called as it requires a single incision that is later hidden in the folds of the belly button. This contrasts with the conventional approach to minimally invasive surgery that leaves four puncture holes in the patient’s abdomen required by a surgeon to triangulate graspers, scissors and the endoscope at the surgical site. Patient demand is driving a rapid acceptance of SPA with the scar-free belly button approach. Within two years of the technique’s introduction in 2007 by Paul Curcillo, MD, of Drexel University (Philadelphia), more than 5,000 SPA procedures have been performed in the U.S. alone, rapidly expanding from cholecystectomy to diverse applications for organ removal and bariatric treatments. Yet inserting multiple instruments into the three to four ports packed into a narrow SPA device leads to “swordfighting” because the surgeon is working along the same line with all instruments and no longer can triangulate. This instrument clash, also called the “chopsticks effect” is not unlike trying to turn a steak on the grill using two forks with your wrists tied together, Olympus and Karl Storz responded to this challenge created by their SPA ports by designing a new line of instruments with curved handles, requiring a new level of investment in dedicated tools for single-port surgeries. Covidien’s solution is to cross the shafts of the instruments resulting in the disorienting exercise for surgeons of watching left hand actions on the right side of the monitor and vice versa for the right hand. Applied Medical’s GelPOINT is built on the company’s Alexis abdominal retractor, a flexible ring inserted through an incision as small as 1.5 cm that atraumatically expands soft tissue to expose a wider opening to a surgical site. The GelSeal cap is placed on top of the ring creating a soft surface giving the surgeon a 360-degree working platform above the surgical site inside the abdomen into which 5 mm access ports can be placed as required to triangulate instruments. GelPOINT also can be used at any other point on the abdomen so that single-incision surgery is not restricted to an umbilical access, though this leaves a visible scar up between 1.5 cm and 7 cm. The GelPOINT assembly includes a stopcock valve to maintain insufflation of the patient’s abdomen during surgery. The single-use package from Applied Medical for the GelPOINT advanced access platform includes four trocars with a retaining disk on the distal tip of the cannula that stabilizes the tube once it is inserted through the GelSeal cap The GelSeal cap can be removed during a procedure to extract an organ. GelPOINT became available in the U.S. in mid- September and the company has filed for CE mark approval, which Gary Johnson, President of the Surgical Group at Applied Medical told MDD he expects to receive before the end of October. Johnson also confirmed GelPOINT is currently being investigated as an access platform for robotic surgery. A paper published online in March, 2009 in the European Urology Journal authored by Robert Stein from the Cleveland Clinic describes the results of 11 laparoendoscopic single-site surgeries using GelPOINT with the da Vinci Surgical System from Intuitive Surgical (Sunnyvale, California). Stein et al concluded that the Applied Medical access platform provided “adequate spacing and flexibility of port placement and acceptable access to the surgical field for the assistant, especially during procedures that require a specimen extraction incision.” (This story originally appeared in the Oct. 5, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 ARS measures effectiveness of anti-depressant medications By OMAR FORD Medical Device Daily Staff Writer It’s estimated in the U.S. that nearly 15 million people experience a depressive disorder every year and that nearly 17% of adults in the U.S. will experience major depression in their lifetime. And in that number research has shown that many patients looking to treat their depression won’t respond adequately to the first antidepressant treatment they are prescribed. So finding the right kind of treatment for major depressive disorders is often challenging for patients and doctors alike, but a new application by Aspect Medical (Norwood, Massachusetts) might help eliminate some of the difficulties. Results from the clinical study Biomarkers for Rapid Identification of Treatment Effectiveness Trial in Major Depression (BRITE), show that Aspect’s EEG-based Antidepressant Treatment Response indicator, is a significant predictor of patient response and remission after one week of treatment with the commonly prescribed antidepressant escitalopram. The company suggests that ATR has the potential to positively impact depression treatment outcomes by helping clinicians select the most effective antidepressant for each patient early in their treatment. The BRITE trial was conducted in collaboration with investigators from nine facilities throughout the country and saw 375 patients. Their response was defined by researchers as a 50% improvement in depression symptoms as measured by the Hamilton Depression Rating Scale after seven weeks of treatment, and remission was defined as recovery from depression after seven weeks of treatment. In the study, ATR at one week predicted the response and remission with 74% accuracy in subjects treated for seven weeks with escitalopram, which was statistically significant. These results were then published in the September issue of the journal Psychiatry Research. “The results of the trial have been reported in various scientific sessions, but this is the first peer-review publication of these results,” Amy Siegel VP of Strategic Marketing for Aspect Medical told Medical Device Daily. “This is pretty significant.” ATR works by using six sensors to measure electrical activity in the brain and translate it into a number between 0 and 100. Two of the sensors are placed on the ears and the rest are placed along the head. The sensors hook up to a laptop which measures the EEG. The test can be taken in an office setting within 10 to 15 minutes. Patients first get readings prior to taking medication, then another about a week after the anti-depressant medicine is administered. The lower the score, derived from the ATR index the least likely a patient is to respond to the treatment. “You don’t know how someone is going to respond to treatments,” Andrew Leuchter, MD a professor of Psychiatry at the Semel Institute for Neuroscience and Human Behavior at University of California Los Angeles, principal investigator for the trial, and chair of Aspect’s Neuroscience Advisory Board told MDD. “What ATR does is lets us see within one week if patients are going to respond to the therapy or not.” Leuchter, who helped develop the device at UCLA back in 2002 added that, while using ATR on patients doesn’t predict the right dose of medication, it does give info on if the right medication is being used to treat the illness. “BRITE study results suggest that ATR could potentially provide the greatest clinical benefit for those patients who might be receiving a medication that is unlikely to help them. Our results suggest that it may be possible to switch these patients to a more effective treatment quickly. This would help patients and their physicians avoid the frustration, risk and expense of long and ineffective medication trials,” said Leuchter. “Research has shown that depression patients who do not get better with a first treatment attempt experience prolonged suffering, are more likely to abandon treatment altogether from lack of efficacy and may become more resistant to treatment over time.” In the future, the company plans to continue the ATR research effort and conduct a multi-year follow-on study of ATR called the PRISE-MD study (Personalized Response Indicators of SSRI Effectiveness in Major Depression). This study will is expected to prospectively evaluate the ability of ATR to predict response to escitalopram as well as the clinical utility of ATR-directed treatment with escitalopram or an alternate treatment with bupropion. Funding for this study comes from a grant from the National Institutes of Health. Phillip Devlin, VP of Emerging Tech at Aspect said that the company is currently in talks with the FDA to decide what regulatory path it would proceed down to obtain market clearance of ARS, but stopped short of saying what that clearance might be. “This is very promising research,” Devlin touted. Based on the findings, the company said it would be realistic to expect to see the device commercialized in the next five years. (This story originally appeared in the Sept. 14, 2009, edition of Medical Device Daily) 13 To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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