MASSDEVICE ON CALL — Medtech titan Medtronic (NYSE:MDT) rocked the renal denervation world when it reported earlier this month that it’s bellwether Symplicity clinical trial failed to meet efficacy expectations when compared to a sham control arm.
Hypertension
Medtronic misses efficacy endpoint in Symplicity renal denervation trial
Medtronic’s new renal denervation trial examines less-severe hypertension
Renal denervation may help the heart on its own | MassDevice.com On Call
MASSDEVICE ON CALL — Renal denervation, studied primarily in treatment of hypertension, may product benefits to heart health independent of those generated by lowering blood pressure, according to researchers reporting results from a small study.
The clinicians cautioned that the results are very early and need confirmation from a larger study, but were worked up about the findings.
St. Jude Medical halts Enlightn IV trial
St. Jude Medical (NYSE:STJ) is calling off the Enlightn IV trial of the next generation of its renal denervation technology, just a few months after it began.
Hypertension: Ablative Solutions lands $8M for renal denervation tech
Ablative Solutions, which is developing perivascular renal denervation technology for treating high blood pressure, raised an $8.0 million funding round, according to a regulatory filing.
Menlo Park, Calif.-based Ablative Solutions said 98 unnamed investors participated in the funding round, which consisted of debt, options and warrants.
Medtronic begins U.S. trial of renal denervation in lower-risk patients
Deflating the hype: Are we setting renal denervation up for disappointment?
Renal denervation is still in its youth, but the limited clinical trials and lack of substantial confirmation hasn’t curbed much of the hype for the technology as a means of treating patients with resistant hypertension.
Kona Medical raises $10M Series D
Kona Medical said it closed a $10 million Series D round it plans to use to enter the Chinese renal denervation market.
Unlike other renal ablation systems, Kona’s Surround Sound device uses external ultrasound to non-invasively target the nerves leading to and from the kidney.
Cardiosonic closes 1st-in-human renal denervation trial, launches 2nd study
Cardiosonic Ltd. said it’s completed a 1st-in-human trial of its Tivus renal denervation device and has launched a 2nd trial.
The Tel Aviv-based medical device company is developing the Tivus device to treat high blood pressure using renal denervation. Unlike other renal denervation technologies that use radiofrequency energy to ablate the nerve lining the renal arteries, the Tivus device uses ultrasound waves.
Sotera lands FDA OK for wireless blood pressure monitor | MassDevice.com On Call
MASSDEVICE ON CALL — Sotera Wireless this month touted FDA clearance for a new feature of its ViSi Mobile continuous non-invasive blood pressure system, now able to monitor patients without the use of a catheter or blood pressure cuff.
The novel new device has long been part of Sotera’s product portfolio, but wasn’t cleared alongside earlier ViSi Mobile systems.