Digestive System

Med Device Monday: Flourish Esophageal Atresia and Humanitarian Devices

1 in 2,500 babies in the United States are born with esophageal atresia, a congenital defect in which the upper and lower parts of the esophagus don't properly connect in utero. Typically, affected infants have problems with eating and require a feeding tube until they're large and stable enough to have surgery performed to connect the esophagus. 

A device approved in May of 2017, Flourish Pediatric Esophageal Atresia Device, offers a different, less invasive, and innovative new solution. Flourish uses two magnets to slowly connect the two parts of the esophagus. As they explain, "Over the course of several days, the magnets gradually stretch both ends of the esophagus, after which the tissue connects to form an intact esophagus. To date, 16 patients have been successfully treated with this device."

The magnets are inserted through catheters in the mouth and via the abdominal wall, as shown:

Photo from cookmedical.com. 

Photo from cookmedical.com. 

It's important to note that the device cannot be used in patients with tracheoesophageal fistula, a condition commonly found in those with esophageal atresia. However, if a fistula has been repaired, Flourish can be used. Additionally, of the 16 treated patients, 13 required a follow-up procedure to fix narrowing of the newly formed esophagus. Notably, this is a complication that is common with the traditional surgical repair as well. 

What makes this innovative device even more special is that was granted approval from FDA via the Humanitarian Use Device (HUD) pathway. A HUD is defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (thanks to the 21st Century Cures Act, the population estimate was changed from "fewer than 4,000" to "not more than 8,000" this past December). In order to pursue approval via this pathway, an application is filled out and submitted to FDA. It's somewhat similar to a Premarket Approval Application (PMA), but does not have the effectiveness requirement of a PMA. However, it "must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market."

In 2007, title VIII of the Food and Drug Administration Amendments Act (FDAAA) included a provision that all applications via the Humanitarian pathway are required to include certification that all applicable clinical trial information has been submitted to the ClinicalTrials.gov data bank. 

You can check out the list of FDA's approved Humanitarian Devices on their website.



Further reading:

RAPS article about Flourish

FDA press release about Flourish


Med Device Monday: Obalon Weight-Loss Balloon System

Over the past decade or so, there have been a host of developments in the arena of weight-loss surgeries. Far from the basic stomach stapling days of yore, there are many options now available to those in need of a surgical option to lose weight. There are generally two types of bariatric surgeries: one works by reducing the absorption of food into the body (think gastric bypass), and the other works by physically reducing the amount of food that the stomach can hold (think lap-band). FDA offers a list of various types of bariatric surgeries and obesity treatment devices that it has approved.

Screenshot from obalon.com.

Screenshot from obalon.com.

One of the most recently approved of these volume-reducing devices is the Obalon Weight-Loss Balloon System. What seems like a space-age idea is now reality: this is weight-loss in a pill! Well, but not the way you'd think. A capsule attached to a catheter is swallowed, and once in the stomach the outer shell is shed to reveal a balloon, which is then inflated via the catheter. The catheter is removed and the balloon remains in the stomach for six months. During this six month period, two other balloons are added, for a total of three. With extra space taken up in the stomach, the patient feels full sooner and thus eats less. At the end of six months the balloons are removed via catheter.

Watch how it's done:

The concept is quite powerful in its simplicity. The power of change is still with the patient, making Obalon a tool: "The Obalan Balloon System assists with weight loss by taking up space so that you eat smaller amounts of food. This, along with diet and exercise, jump-starts your efforts, proving that when it comes to losing weight, less is truly more." 

This is also, of course, how it's explained in FDA's information on this recently approved device:

"When is it used? The device is used to treat adults with obesity who have a Body Mass Index (BMI) of 30-40 kg/m2 and who have been unable to lose weight through diet and exercise. The Obalon Balloon System is intended to be used while a patient participates in a moderate intensity diet and exercise program.

What will it accomplish? During the clinical study, the group of patients who used this device lost more weight than those who did not use it. The study included a total of 419 subjects, of whom 387 were able to successfully swallow the device. A total of 198 subjects received the Obalon device and 189 received a sham device (a capsule without a balloon). All study participants received diet and exercise counseling.

Patients with the Obalon Balloon System lost an average of 14.4 pounds (6.6% of their total body weight). The patients who received the sham device lost an average of 7.4 pounds (3.42% of their total body weight)."

This more safe and simple procedure is pretty ground-breaking, and I'd be interested to know what the long-term results are and how this device may help change habits. As ever, I look forward to seeing how technological developments continue to improve upon existing ideas to make them safer and more effective. 

Read more:

FDA's approval letter for Obalon Balloon System

Obalon Balloon FAQs 

FDA's Obalon Summary of Safety and Effectiveness Data (SSED)

Patient Labeling 

Professional Labeling