Several medical device companies – including three of the largest in the U.S. – have been accused of encouraging doctors to use their surgical ablation devices for unapproved uses by offering illegal kickbacks. According to newly unsealed documents in Houston federal court, Boston Scientific (Natick, Massachusetts), Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota), AtriCure (Westchester, Ohio), Endoscopic Technologies (San Ramon, California), and St. Jude subsidiary Epicor Medical (Sunnyvale, California) are named in the whistleblower lawsuits. (Medical Device Daily)
For about the last 30 years, anytime a patient has colorectal surgery, either for cancer or for inflammatory diseases like ulcerative colitis, they have to worry about certain risks associated with the post-operative healing process due to the use of surgical staples, which can crush and puncture tissue. Leakage, inflammation, infection, and bleeding are the primary concerns with this method of bowel closure. (Medical Device Daily)
ConforMIS (Burlington, Massachusetts), a private device company that makes custom implants and instruments for osteoarthritis treatment and joint damage, said it has raised $50 million – its largest round of funding to date – from private-equity and sovereign-wealth funds in the U.S., Asia, Europe and the Middle East. ConforMIS reached this milestone in June, in a process that began in 2008, the company said. (Medical Device Daily)
When Gloria Gogola, an orthopedic hand surgeon specializing in pediatrics, visited a senior design class at Rice University (Houston) and challenged students in the class to create a device that accurately measures intrinsic hand muscles, the students saw it as an opportunity to make a real difference in a clinic setting. (Medical Device Daily)
After using a new PFO closure device on opposite sides of the globe, two cardiologists say they are not surprised that the Coherex FlatStent EF PFO Closure System has received a CE mark for use in closing patent foramen ovales (PFOs). (Medical Device Daily)
Women looking for permanent protection from pregnancy now have a less invasive option than getting their tubes tied. Hologic (Bedford, Massachusetts), a developer of diagnostics, medical imaging systems and surgical products intended to serve the healthcare needs of women, said the FDA has approved its premarket approval application for the Adiana permanent contraception system. (Medical Device Daily)