Spinal Cord Stim From Boston Sci…

Boston Scientific Corp. is launching its Precision Novi spinal cord stimulator in Europe, the firm announced June 4 at the International Neuromodulation Society meeting in Montreal, Canada. The 16-contact primary cell device earned a CE Mark for the treatment of chronic pain. According to the company, it is the smallest high-capacity primary cell device currently. Boston touts its enhanced shape intended to improve comfort to patients with pain.

…And St. Jude

St. Jude Medical Inc. announced June 4 the CE Mark approval and the European launch of its Invisible Trial System for test-running spinal cord stimulation as a treatment option for chronic pain prior to receiving a permanent implant. Its app-based and wireless neuromodulation programming system that allows patients to adjust therapy via an iPod touch and physician's to set programming parameters via an iPad mini. The system relies on an external pulse generator as the stimulation power source that can communicate with the iPod touch via Bluetooth. It delivers stimulation in both traditional and Burst modes, the latter which has been demonstrated to minimize paresthesia in most patients, St. Jude says.

Medtronic Diabetes Enters App Space

Medtronic PLC's MiniMed Connect secondary display device gained 510(k) clearance to enable people with diabetes to view their insulin pump and continuous glucose monitor (CGM) data on a smartphone and provide remote monitoring and text message notifications from the data to loved ones or caregivers, the company announced June 5 from the American Diabetes annual meeting in Boston.

The system consists of a small device that can fit on a keychain or in a pocket and transmit insulin pump and CGM data to a mobile Apple iOS smartphoneapp and a remote web display. It can be programed to deliver preset text notifications to loved ones when a diabetic's glucose value goes too high or too low, or when an alarm on the pump isn't cleared. It can also provide more comprehensive data to health care teams to facilitate adjustment of care plans as necessary. Medtronic says it is working with Samsung to develop an app for the Android mobile operating system (Google Inc.) that is optimized on Samsung mobile devices. MiniMed Connect is compatible with the MiniMed 530G system and the MiniMed Revel pump-monitor systems.

Dexcom Goes Android

The continuous glucose monitor firm's Dexcom Follow app is now available on mobile devices that run Android, DexCom Inc. announced June 2. The Follow app, already available on Apple Inc. iOS devices, allows up to five people to view data from the G4 Platinum Continuous Glucose Monitoring System with Share continuous glucose monitoring system. It is intended to allow family or caregivers remote access to a diabetic's glucose levels and trends. It works with the Dexcom Share2 app, only available on iOS, which allows the patient to view track her own CGM data. The G4 system with Share was FDA-approved with a built-in wireless receiver earlier this year. (See [A#01150202005].) In April, Dexcom announced that the system and its apps are compatible with the recently launched Apple Watch.

G4 Platinum sensor and transmitter

Photo: Dexcom Inc.

Cyberonics Responsive VNS Generator

The AspireSR generator for Cyberonics Inc.'s VNS Therapy vagus nerve stimulation system gained PMA supplement approval May 29. In a June 2 announcement, Cyberonics says the system is now the first VNS therapy to deliver stimulation in response to heart-rate increases often associated with epileptic seizures. The AspireSR generator uses a proprietary, patent protected, customizable cardiac-based algorithm to detect relative heart-rate increases and deliver automatic stimulation. AspireSR was CE marked in Europe in 2014. Earlier versions of the VNS Therapy system have been on the U.S. market for treating drug-resistant epilepsy. Responsive neurostimulators are a growing focus in the neurology space. In 2013, NeuroPace Inc.'s RNS system, also targeting epilepsy, became the first responsive neurostimulator to gain FDA approval, but that device works by responding to abnormal brain activity rather than heart rate. (See Also see "NeuroPace’s RNS For Epilepsy Becomes First FDA-Approved Responsive Neurostimulator" - Medtech Insight, 14 November, 2013..)

SurgiBot Submission

TransEnterix Inc. submitted a 510(k) for SurgiBot, the first patient-side, robotically enhanced laparoscopy platform, the firm said June 1. Rather than performing a robotic-assisted procedure from a removed location, SurgiBot is designed so the surgeon operates the robot and laparoscopic instruments at the bedside, preserving tactile feedback that is not available from current robotic systems such as da Vinci (Intuitive Surgical Inc.), according to the firm. TransEnterix plans to position the system as a less expensive alternative to da Vinci. Once cleared, the firm has said it will initially target general abdominal surgery procedures. (See Also see "MIS 2014, Part 2: Opportunities And Challenges" - Medtech Insight, 14 August, 2014..)

Roche Assay

Roche has gained 510(k) clearance for the cobas HSV 1 and 2 test for the direct detection and differentiation of herpes simplex virus-1 and herpes simplex virus-2 DNA in anogenital specimens from symptomatic patients. The test, performed on the cobas 4800 system, relies on dual target detection and automation to report up to 94 results in "significantly less time than traditional methods and provides a simplified workflow for sample handling in the laboratory," according to Roche, which announced the clearance on June 4.

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