EndoBarrier

GI Dynamics’s EndoBarrier is intended to treat obese patients with type II diabetes who no longer see results from lifestyle changes and oral diabetes medications. The device, which consists of a flexible tube placed in the intestine through the mouth, blocks food from making contact with the intestinal wall, thereby preventing it from interacting with enzymes and hormones involved in insulin sensitivity, glucose metabolism, satiety, and food intake. The device, which is not yet available in the United States, suffered a setback earlier this year when...
July 24th, 2015
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Boston Scientific's Lotus TAVR

Boston Scientific's Lotus Valve system is a transcatheter aortic valve that allows physicians to reposition and retrieve it before placement. Lotus earned CE Mark in October 2013 but is being studied in the REPRISE III pivotal trial in the United States.

Boston Scientific executives recently reported strong results in its Structural Heart division, naming Lotus as a significant contributor to that strength. At the company's recent investor day meeting, executives forecasted a U.S...

July 24th, 2015
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U.S. patients are missing out on some medtech innovations. Here are some of the medical devices that aren't yet commercially available to patients in the United States. 

 

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Patients in the United States enjoy some of the best medical care in the world, but many observers worry that the country's regulatory environment is pushing medical innovation to other shores. Whether you believe FDA oversight is too stringent, too lax, or strikes the right balance, there are numerous medical devices that have achieved CE Marking, but aren't yet FDA approved.

Here are 10 hot medical devices that have CE Mark, but are not yet available for commercial use in the United States.

July 24th, 2015
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Alair System

Boston Scientific’s Alair system is used to treat severe asthma via a procedure called bronchial thermoplasty. The device consists of a wire electrode array that delivers controlled radiofrequency energy to the airway walls, reducing smooth muscle that contracts and narrows during an asthma attack and makes it difficult for asthma sufferers to breathe. According to the company, patients who underwent the procedure saw a 32% decrease in severe asthma exacerbations requiring systemic corticosteroids.
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July 24th, 2015
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Brainsway Deep TMS

Brainsway's Deep Transcranial Magnetic Stimulation (TMS) technology treats major depressive disorder in patients who didn't get good results from antidepressant drugs. The system uses a helmet containing the company's proprietary H-coil to deliver magnetic stimulation to deep brain tissue, which can help regulate mood. It was cleared by FDA in 2013. 
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July 24th, 2015
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Cefaly

Cefaly, made by Cefaly Technology, uses low-frequency neurostimulation targeted at the trigeminal nerve to treat and prevent migraine headaches. Available via prescription, the device can provide an alternative to medication for some patients. Cephaly was cleared through FDA’s de novo pathway in March 2014.
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July 24th, 2015
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Alpha-Stim M

The Alpha-Stim M, made by Electromedical Products International, uses a current passed between two electrodes to noninvasively provide relief from pain, anxiety, depression, and insomnia. The company says it can help users avoid or reduce the need for medications as well as be used safely in conjunction with them. Last year, FDA reclassified devices such as the Alpha-Stim M that provide cranial electrotherapy stimulation from Class III to Class II medical devices.
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July 24th, 2015
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These medical devices are encroaching on pharma's turf and could someday supplant drugs. 

The U.S. pharmaceutical market is roughly double the size of that for medical devices. Perhaps sensing an opportunity, some device firms are moving in on drug makers' territory.

Could these medical devices someday replace drugs?

 

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July 24th, 2015
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Stryker's bold acquisition of MAKO Surgical in 2013 may be finally bearing some fruit.

Arundhati Parmar

Stryker made a bold acquisition in 2013 when it bought MAKO Surgical for $1.65 billion betting on the fact that the future of orthopedics industry lay in robot-assisted surgery.  

The integration of the two company's sales teams was harder than expected.  While analysts were surprised and hopeful about the acquisition, the number of units sold disappointed both them and company management through most of 2014.  

Training and coordination of the sales teams were a particular...

July 24th, 2015
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Boston Scientific's Watchman device performed well in the recent quarter, but analysts are focused on upcoming reimbursement decisions for the device and the potential impact on Watchman adoption going forward.

Marie Thibault

Boston Scientific's Watchman Left Atrial Appendage Closure device is the anticipated subject of upcoming reimbursement changes.

Boston Scientific is a large medtech company, with a wide range of products encompassing cardiac, vascular, urology, gastroenterology, and other treatment areas. But anyone listening to the company's recent second quarter earnings call wouldn't have known it, because much of the discussion focused on just one product—the Watchman Left Atrial Appendage Closure device.

More specifically,...

July 24th, 2015
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