Boston Scientific has settled part of a series of lawsuits alleging the devicemaker’s transvaginal mesh product for urinary incontinence is defective and causes complications, the Marlborough, Mass., company said. Boston Scientific plans to pay an estimated $119 million to resolve 2,970 cases, a fraction of the more than 25,000 mesh claims it is contending with in U.S. federal and state courts. The agreement is tied to a $35 million verdict in a Dallas County, Texas, district court case that is subject to appeal. The company lost two federal trials, in West Virginia and Miami, and was ordered to pay $18.5 million and $26.7 million, respectively. Women complained of suffering pain, bleeding, infection and injury while using the Pinnacle device. The devicemaker denied allegations the product was to blame for plaintiffs’ complications and won its first two mesh cases in Massachusetts state court.
Uterine Balloon Tamponade Developed
Cambridge Design Partnership is seeking funding for its Uterine Balloon Tamponade designed to help medical professionals treat life-threatening postpartum hemorrhage, specifically in developing countries, the UK devicemaker said. Current UBTs cost as much as $200 and have to be inserted by trained clinicians, which limits their use in developing countries. Cambridge’s UBT is meant to bridge the gap between commercial and condom catheters, lowering costs and allowing for patient safety when administered by minimally trained birth assistants. The devicemaker is seeking partners and funding to continue the UBT’s development process.
Stent Graft System Clinical Trial Starts
Medtronic has launched a clinical study to evaluate the efficacy of the Endurant Evo abdominal aortic aneurysm treatment stent graft system, the Ireland-based devicemaker announced. The company recently conducted the first implant of the device. The multicenter clinical trial will enroll 140 patients at up to 30 sites in the U.S. and Europe. The study’s primary safety endpoint has been designated as the proportion of patients experiencing a major adverse event within 30 days of implantation. The FDA has designated the device for investigational use only.
Abbott Pregnancy Test Gets FDA Nod
Abbott’s i-Stat Total ?-hCG pregnancy blood test has won FDA regulatory approval, the Abbott Park, Ill., devicemaker announced Thursday. The first-of-its-kind blood test rapidly and accurately detects the hormone commonly associated with pregnancy, the company says. By measuring very low hormone levels in the blood, the test can determine if a woman is in the early stages of pregnancy within 10 minutes. Previously, medical professionals had to rely on urine-based testing, which can be difficult if a woman in an emergency setting is dehydrated, experiencing pain or unconscious. By displaying results that specify the amount of the hormone present, the i-Stat test could potentially cut down on false-negative readings.
The i-Stat blood test is currently available in Canada, Europe, the Middle East, South Africa, Australia and New Zealand.