Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Intuitive Surgical recalls da Vinci cannulae
Intuitive Surgical said it’s recalling some of the cannulae used during procedures with its da Vinci robotic surgery system, saying they can become damaged if not installed properly by the user.
Sunnyvale, Calif.-based Intuitive said it’s recalling 129 lots of its Single-Site 5mm reusable curved cannulae made between December 2010 and August 2012. One patient was allegedly injured by cannula damage when the device pierced the abdominal muscle. The injury did not require surgical or medical intervention, the company said. An Intuitive Surgical spokesman told MassDevice.com via email that “[a]ffected products were sold to approximately 600 customers and involve approximately 5,200 cannulae.” Read more
2. Sapien XT bests CoreValve in small head-to-head study
Edwards Lifesciences shares gained today after a small study showed that its Sapien XT replacement heart valve tops the CoreValve device made by Medtronic in terms of overall “device success.”
The 241-patient Choice trial of the 2 transcatheter aortic valve implants showed device success in 95.9% of patients implanted with the Sapien XT device, compared with 77.5% of patients in the CoreValve arm. “Device success was defined as “successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location.” Read more
1. Medtronic details Symplicity renal denervation data
Medtronic revealed the details of a clinical trial of its Symplicity renal denervation treatment for hypertension, but said it still plans to investigate the treatment even though the study showed only meager improvements in high blood pressure compared with a sham procedure.
In a widely anticipated presentation of data from Medtronic’s Symplicity HTN-3 trial in Washington today at the American College of Cardiology’s annual meeting, 1 of the study’s lead investigators said the renal denervation arm showed only a 2.39mm Hg reduction in systolic blood pressure after 6 months. Ambulatory systolic pressure, measured over 24 hours, was down 1.96mm Hg for the Symplicity arm. There were no significant differences in safety between the study’s 2 groups, Dr. Deepak Bhatt said. Read more
