Boston Scientific lands expanded FDA indication for biliary stone removal with CRE dilator
Boston Scientific (NYSE:BSX) announced expanded FDA indication for its CRE wire-guided balloon dilators, allowing the Natick, Mass.-based device maker to market the device for dilation-assisted extraction of difficult-to-manage stones in the biliary duct.
The new labeling adds to the device’s existing clearance for dilation of narrowed areas of the digestive tract.
"The CRE wire-guided balloon dilator for the DASE procedure provides a new and alternative endoscopic therapy for the more than 60 million people worldwide affected by the presence of stones in the common bile duct," endoscopy division president David Pierce said in prepared remarks. "The CRE wire-guided Balloon Dilator is a core product in our endoscopy portfolio, and it underscores our ongoing commitment to advancing treatments that meet the needs of patients and physicians."
Physicians quoted by the med-tech giant added that the device was easy to use and could replace traditional methods for endoscopically removing large bile duct stones.
Medtronic touts CE Mark approval for its Shilla growth guidance systems
Medtronic (NYSE:MDT) announced CE Mark approval in the European Union for its Shilla growth guidance system, used to correct and maintain spinal deformities associated with early-onset scoliosis.
The device is the company’s 1st growth-guided system specifically for growing children, aiming to allow natural growth and deformity correction without resulting to additional spinal operations
Teleflex wins 510(k) for its next-gen Arrow epidural catheter
Teleflex won 510(k) clearance for its Arrow FlexTip Plus epidural catheter , the latest it in the Arrow family to hit the U.S. market. Studies showed that the device reduces complications associated with epidural catheters, including vein cannulations and paresthesia.