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.
4. SRS Medical touts Spanner prostate stent data
SRS Medical announced the clinical efficacy data of its Spanner Temporary Prostate Stent, according to a May 10 press release. The study analyzed 214 stent placements in male patients who had symptoms of benign prostatic hyperplasia (BPH). The data showed that the fully-internal device can effectively restore natural urination with a low infection rate. The Spanner was able to maintain natural urination while reducing the measure of urine that remained in the bladder after voiding by 81%. The devices were implanted for 30 days during the study and only 6 of them resulted in symptomatic urinary tract infection.
5. Lensar signs distribution deal
Lensar announced in a May 10 press release that it has selected Teleon Surgical as its European distributor for its femtosecond laser cataract platform, the Lensar Laser System with Streamline. Teleon will begin contacting Lensar customers in the EU for full service, sale, training and support starting June 1.
6. InBrace launches invisible orthodontics line
InBrace has launched a new technology to straighten teeth, according to a May 9 press release. The new braces hide behind the teeth and use a space-age memory wire to straighten teeth. It is designed to decrease treatment time and doctor visits for patients and allows for normal brushing and flossing, unlike clear aligners. InBrace’s braces are available through a licensed orthodontist.
7. India approves ZipLine Medical’s Zip wound closure system
ZipLine Medical announced in a May 9 press release that its Zip Surgical Skin Closure system has received Central Drugs Standard Control Organization approval in India. The approval gives ZipLine Medical access to India’s $3.5B medical device market. The Zip is non-invasive and replaces sutures, staples and glue for surgical incisions and lacerations. Studies have shown that using the Zip has resulted in significant time savings and less procedure variability which in turn could reduce hospital costs and improve efficiency.