Briefs

Australia Issues Advisory on Insulin Pump

Australia’s Therapeutic Goods Administration (TGA) announced that Australasian Medical & Scientific Limited, in consultation with the TGA, is issuing a safety advisory regarding the Animas Vibe insulin pump due because battery compartment damage might affect the supply of power to the unit.

According to the announcement, the pump might lose its waterproof capability and/or the ability to maintain a reliable power connection between the battery and the battery contacts if the compartment is cracked, such as from being dropped or overtightened.

The pump’s alarms may fail if the battery power is interrupted, the announcement said. In addition, moisture in the pump can contribute to pump failure and suspend insulin delivery.

Australasian Medical & Scientific Limited advised pump users to regularly inspect their pump for cracks and replace the pump battery cap every six months.

$11.5 Million Raised for EU Device Startups

MD Start, a Europe-based accelerator specializing in developing medical devices, announced that it has raised $11.5 million in a round of funding for its new accelerator, MD Start II.

The round was led by French Tech Acceleration and managed by Bpifrance, the French public investment bank, as well as Medtronic, Sofinnova Partners, and LivaNova.

MD Start II will continue to incept, finance, and develop startup companies aimed at bringing innovative medical device concepts to the market. The companies will be incubated and managed by the MD Start partners until they reach certain milestones and require dedicated management and traditional venture capital funding.

MD Start II is the sixth investment of the French Tech Acceleration fund, which was created in 2014 as part of the French Tech initiative.

Second Recall for Medtronic Catheter

Medtronic has issued a second recall on its brain aneurysm treatment catheter.

The Pipeline device was originally recalled in April 2014, as well as its companion Alligator embolism retrieval device, based on reports that the plastic coating applied to the guidewire can delaminate and detach from the devices. The FDA cleared Pipeline’s return to market in August 2014 after the problem was corrected.

The problem has resurfaced, however, leading Medtronic to recall the Pipeline and Alligator products, plus the X-Celerator hydrophilic guidewire and the UltraFlow and Marathon flow-directed micro-catheters.

More than 84,000 units, made from July 2014 to September 2016, are affected by the recall, the company said. The recall does not affect the next-generation Pipeline Flex device, which won FDA approval in February 2015.

FDA Classifies Prosthetic Device as Class II

The FDA is classifying a device with the generic name of “upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components” into class II (special controls).

The device is a prescription device intended to replace a partially or fully amputated or congenitally absent upper extremity. The special controls that will apply include, among others, electronic input, battery, and software testing.

The classification is based on the FDA’s approval in 2014 of a prosthetic device submitted by DEKA Integrated Solutions Corporation. According to the agency, any manufacturer that makes a similar device will have to meet the same requirements.

The Federal Register notice is available at www.fdanews.com/10-17-16-prostheticdevice.pdf.