1. Obalon receives approval to commercialize in Middle East
Obalon Therapeutics announced in a May 11 press release that it has received regulatory approvals in select Middle East markets to commercialize its 6-month, gas-filled intragastric balloon system. The FDA-approved, swallowable balloon system is designed to treat obesity and is the first and only system of its kind. The regulatory approval also accounts for its associated inflation dispenser. Obalon Therapeutics plans to fulfill an initial order for its Middle East distributor Bader Sultan during the second quarter of 2017.
2. Biotronik touts home monitoring data
Biotronik published results for its Home Monitoring system for ICD patients, according to a May 11 press release. The data showed that the system reduced the risk of all-cause mortality in ICD patients after one year by 38%. It also showed that there was a 36% reduction in the combined risk of all-cause mortality and hospitalization for heart failure. The study gathered data from 2,405 patients from the Trust, Ecost and In-time trials. In-time showed a more than 50% risk reduction in all-cause mortality in ICD and CRT-D patients who have symptomatic heart failure.
3. Bioness, Ottobock ink EU distribution deal
Bioness and Ottobock announced in a May 10 press release that they are partnering up to expand distribution and access of functional electrical stimulation (FES) technologies in the EU, UK, Switzerland, Norway, Turkey and India. The 2 companies will combine their technologies and resources to transform the mobility management paradigm, deliver medical solutions and expand the reach of products. Ottobock plans to begin product commercialization in September this year and distribute the Bioness FES portfolio for its L300 Go System and H200 Wireless System for lower and upper extremities.