Dune Medical Devices Ltd., of Caesarea, Israel, reported the publication of a study demonstrating that proper use of its intraoperative margin assessment device, Marginprobe, results in a significant identification of positive margins and a reduction in the re-excision rate for breast conserving surgery. Published in the March 2018 issue of American Journal of Surgery, the study analyzed Marginprobe's effectiveness by comparing 120 consecutive breast conserving surgery cases prior to use of the probe and 120 consecutive cases after implementation of its use. Reliability of the device was determined by confirming findings with postoperative pathology reports. The researchers reported a 61 percent reduction in the relative re-excision rate when using the Marginprobe compared to the historical comparison group. The study also showed that there was no difference in tissue volume removed between the control group and the device group, demonstrating that a significant reduction in re-excision can be achieved without a negative impact on cosmetic outcome.
GE Healthcare, of Chicago, and Lantheus Holdings Inc., of North Billerica, Mass., reported the start of a second phase III of the AURORA study, an international, multicenter trial to evaluate diagnostic efficacy of Flurpiridaz 18F injection positron-emission tomography (PET) myocardial perfusion imaging (MPI) in the detection of coronary artery disease (CAD). In this prospective, open-label study, patients with suspected CAD, for whom an intracoronary angiography has been indicated, will undergo a single-photon emission computed tomography MPI and Flurpiridaz 18F injection PET MPI prior to the performance of coronary angiography. The primary endpoint is the diagnostic efficacy of Flurpiridaz 18F injection PET MPI for the detection of significant CAD. The first patient was enrolled in the study in June 2018. A total of 650 patients will be enrolled, with the last patient follow-up projected to occur in August 2020.
Infraredx Inc., of Burlington, Mass., reported the Makoto intravascular imaging system and accompanying Dualpro intravascular ultrasound and near-infrared spectroscopy catheter are now available in Japan. The launch follows a successful spring 2018 limited market release, which included more than 10 hospitals in Japan. The technology received market approval from Japan's Pharmaceuticals and Medical Devices Agency in August 2017.
Integer Holdings Corp., of Frisco, Texas, received FDA and CE mark approval for its new radial access introducer, Radialseal. The Radialseal introducer kit for interventional cardiology has a thin wall sheath design and a hydrophilic coating to ease insertion.
Leica Biosystems, of Nussloch, Germany, reported its live-view telepathology system, the Aperio LV1 IVD, can now be used for on-screen diagnosis in Europe, Canada, Australia and New Zealand. This compact digital pathology system, with a capacity of four slides, navigates like a conventional microscope, but enables real-time remote access to slides in less than 15 seconds.
Modulated Imaging Inc., of Irvine, Calif., received FDA 510(k) clearance for its Clarifi imaging system, which uses spatial frequency domain imaging for noninvasive assessment of tissue health. Clarifi is a non-contact, noninvasive system that measures tissue oxygen saturation, oxyhemoglobin and deoxyhemoglobin. This information can be used in the assessment, management and treatment of peripheral vascular diseases, diabetic foot ulcers, burns, skin flaps and chronic wounds. The company is currently ramping up production of the Clarifi imaging system and expects to start fulfilling orders by the end of 4Q18.
Loughborough, U.K.-based Nemaura Medical Inc. initiated the first of a number of planned studies in support of a submission to the U.S. FDA for approval of the Suguarbeat, and further reported positive interim results from the home-use portion of this initial study. The interim results evaluated data from 25 patients, split approximately equally between type 1 and type 2 diabetics, each wearing Sugarbeat while going about their daily home/work routine for one or two non-consecutive days, for a total of 36 patient days. Each patient recorded up to five finger prick readings per day, at approximately equal intervals, over periods up to 14 hours. Readings were measured using the Abbott Freestyle Optimum Neo blood glucose meter (BGM). The results analyzed 121 matched pair points between the BGM and Sugarbeat, and indicated 84.3 percent of the data points had an overall MARD (Mean absolute relative deviation) of 10.63 percent, and an overall nominal MARD of 16.3 percent (compared with 14.8 percent, 16.3 percent and 18 percent for Eversense, Dexcom G5 and Abbott Libre Pro, respectively). The initial U.S. study is expected to enroll a total of 75 patients wearing the device over a week, including three days in a clinical setting (525 total patient days; 225 total in-clinic days). Initial U.S. study completion and FDA submission is anticipated in 1Q19.
Qosina Cop., of Ronkonkoma, N.Y., reported the launch of a new line of Tyvek sterilization supplies for biopharmaceutical equipment and medical device components. With 54 options from which to choose, the company's off-the-shelf Tyvek sterilization supplies include a large assortment of pouches, sheets and tubes, and are available in many sizes and styles. Qosina's new Tyvek line is compatible with autoclave, steam and ethylene oxide sterilization methods.
Radiadyne LLC, Houston-based developer of the Endorectal Balloon device utilized during radiation therapy for prostate cancer, said a pivotal study utilizing their technology was published July 20 in Acta Oncologica. The study evaluated proton therapy to treat post-prostatectomy patients and demonstrated favorable late term patient outcomes through examination of associated post-treatment toxicity profiles routinely reported for the procedure. "Patients in the study were treated using the Radiadyne Endorectal Balloon device to immobilize the prostatic fossa, provide reproducible anatomy and spare the posterior rectal wall, which was critical to reduce dose uncertainties since protons have a finite range and no exit dose unlike photons," said one of the authors from the study. The study found acute and late term maximum genitourinary (GU) and gastrointestinal toxicities were predominantly grade 0 and 1. Grade 2 GU toxicities were less common, and no grade 3 toxicities were observed through a median two-year follow up.
Rapid Medical, of Yokneam, Israel, received CE mark approval for the Tigertriever 13. In addition, the first patients have been treated successfully with the device. Tigertriever is an adjustable, fully visible clot retriever designed to treat ischemic stroke patients. The new device is designed to recanalize intracranial vessels of 1-2.5 millimeters and is delivered through a neurovascular microcatheter with a soft distal outer diameter of 1.3 French. The company said it will launch the Tigertriever 13 in Europe during 3Q18.
Basel, Switzerland-based Roche AG received U.S. FDA approval for the Cobas HPV test to be used as the first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in Surepath preservative fluid, a collection medium commonly used for Pap tests. The Roche test is now the only human papillomavirus (HPV) test approved for use as a primary screening test with both Surepath and Thinprep Preservcyt solution, the two types of liquid media used to collect samples for the vast majority of Pap or HPV tests in the U.S.
Eden Prairie, Minn.-based Surmodics Inc. reported the launch and immediate availability of Matrixguard diluent. The company said that unlike other diluents that either are marginally effective at blocking matrix interferences or alternatively block out true assay signal, Matrixguard achieves the goal of maximum blockade of matrix interferences while simultaneously allowing the intended signal to be maintained. It is designed to significantly reduce the risk of false positives and has excellent three-year stability.