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Tuesday, 18 June 2013

Device Stops Asthmatic Kids' Inhaler Woes

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By Deanna Pogorelc, MedCity News

Frustrated by the challenges of giving her young son his daily asthma treatments, Sarah Cota came up with an idea. Why not ease the burden of using a nebulizer by taking away the mask and using it while the child is sleeping?

That's the idea behind the JettPak, the flagship product being developed by Bend, Ore., startup JettStream Inc. It's a hands-free, mask-free add-on for nebulizers currently on the market. Intended to deliver medication to the child while he's sleeping, the base of the device can slide under a pillow or mattress.

The JettPak has an adjustable arm that delivers the medication next to the child's face. According to a July blog post from Jim Harrer, an entrepreneur and chief operations officer of the company, it will retail for about $200.

Cota didn't return a call last week, but she told the Cascade Business News earlier this month that the estimated launch date for the device was spring 2013. Right now, the startup is raising money for the launch; it's already secured $115,000 in debt and equity, and could raise up to $750,000, according to a recent U.S. Securities and Exchange Commission filing.

As the company's website notes, it has already done lab testing that shows the device delivers the same doses of medicine as a nebulizer alone, and it's planning to do a clinical trial with 50 devices at Bend Memorial Clinic.

Asthma is the most common chronic childhood disease and affects nearly 5 million U.S. children. In addition to quick-relief medications, long-term control medications taken daily are often prescribed.

Many of these medications can be used with a nebulizer for asthma sufferers who are too sick or young to use an inhaler effectively. But some children show resistance to these administration methods, as detailed in Cota's blog.

She's working with a former product development executive, Matt Smith, and Harrer to bring the device to market.

Companion to the device is JettEducation, an online database being developed for parents, and JettCommunity, a digital support community.

This article was adapted from one that first appeared on Sept. 24, 2012, in MedCityNews.com with permission from MedCity Media.

FDA Panel to Review Safety of Eye Device

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By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- FDA reviewers expressed concern over the long-term safety of what could be the first retinal prosthesis device despite evidence that it helps improve the vision of some nearly blind patients.

Members of the FDA's Medical Devices Advisory Committee will vote Friday on whether to recommend approval of the Argus II Retinal Prosthesis device. Members of the ophthalmic panel also will discuss and recommend possible post-approval study requirements should the device ultimately gain FDA clearance.

The Argus II is designed for use by patients with severe to profound retinitis pigmentosa, who experience progressive vision loss, often leading to blindness.

The device, manufactured by Second Sight Medical Products, is a three-part system. It includes a video camera attached to a pair of eyeglasses, a processing unit, and an implanted retinal prosthesis.

The glasses capture images, which are sent to the processing unit worn on a belt. The processor transforms the images into an electrical stimulation pattern that's sent to the implanted retinal prosthesis.

In the single-arm feasibility study submitted in support of the device, 19 of 30 patients showed no device- or surgery-related adverse events, but FDA staff reviewers cited three notable events that occurred at 2 two years after the retinal prosthesis was implanted.

Events included retinal detachment and retinoschisis, an abnormal splitting of the retina's neurosensory layers, according to briefing documents prepared in advance of Friday's meeting.

"While there are concerns regarding the safety profile based on premarket data, there is also concern about the possibility that the frequency of adverse events could increase over time and/or the events could worsen in severity," staff reviewers wrote.

Draft labeling language for the device warn of a "cascade" of adverse events following an initial minor side effect, the briefing document stated. Four patients in the study experienced this.

Furthermore, the staff reviewers said, the primary endpoint of helping patients correctly see the orientation of grating on squares did not appear to be met.

No patients were able to score reliably without the device, but only eight of 30 were able to score at least once with it on. "The performance of most subjects may indicate that they were not able to use scanning techniques effectively to detect the orientation of the grating bars," the FDA reviewers said.

However, the study met most of its secondary endpoints. Nearly all participants could identify squares better with the device on than off. About half were able to read 8.9-inch letters from a foot away. Also, more patients were able to perform visual orientation from the sun with the device on (80%) rather than off (67%).

There were 18 of 27 patients who performed better at walking along a straight piece of 20-foot sidewalk with the device on. And, 25 of 27 performed better with the device when they were asked to describe the direction a person in front of them was walking.

Second Sight is seeking approval under a humanitarian device exemption.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

Tuesday, 18 June 2013

Device Stops Asthmatic Kids&apos; Inhaler Woes

FDA Panel to Review Safety of Eye Device

Device Stops Asthmatic Kids' Inhaler Woes