Can a Pillow Be a Medical Device?
After suffering most of his life with chronic acid reflux, or gastroesophageal reflux disease (GERD), Carl Melcher, a retired physician and entrepreneur decided to do something about his own condition, while also helping other people who suffer from nighttime reflux.
He formed a company called Amenity Health in 2011 and partnered with engineers and product designers to develop a positional therapy pillow-like device known as MedCline.
“When I met Carl he had been sleeping in a recliner for about a year because as a lot of patients know, sleeping on an incline can help pull the acid back down,” Aaron Clarke, CEO and co-founder of Amenity Health, told MD+DI. “He was just kind of fed up.”
In recent years, Melcher was diagnosed with the esophageal cancer precursor, Barrett’s Esophagus.
“He wanted to develop an effective solution for sleep positioning and he really wanted to take the high road, full-blown clinical studies, that type of thing,” Clarke said. “Being a radiologist, he understood that because of the asymmetry of the stomach, there was an opportunity to optimize the [patient’s sleep] position.”
At first glance, MedCline is a specially designed pillow that encourages the user to sleep on their left side and at an incline.
As decades of medical literature and pH monitoring has shown, Clarke said, sleeping on an incline does improve acid clearance time. Experts in the field use the analogy of putting a finger over a candle flame. You can swipe your finger over the flame quickly and it won’t do much damage to your finger, but if you hold your finger over the flame for a few seconds or more it can do a lot of damage.
In addition to sleeping on an incline, research has shown that having the patient sleep on their slide, particularly their left side, is considerably better than allowing them to sleep on their back or their right side.
“So it seemed logical to combine these sleep positions,” Clarke said.
He said the company spent a couple of years of R&D beta testing with the product prior to taking it down the clinical regulatory path. Today, the MedCline product is registered with FDA as a Class I medical device, but it did not require 510(k) clearance to put the device on the market.
The Cleveland Clinic approached the company to evaluate the device in patients with refractory GERD who had not responded well to medication and are not good surgical candidates.
“They tested MedCline in their worst GERD patients and had phenomenal results,” Clarke said.
The Cleveland Clinic also studied the device in pregnant women who had been suffering from gestational GERD and saw positive results, Clarke said.
The Cleveland Clinic continues to study the product in other patient groups, including lung transplant patients because there is a high prevalence of gastroesophageal reflux after lung transplantation, and the disease can lead to rejection of the new lung.
Amenity Health took the device directly to consumers about two years ago.
“When you go direct-to-consumer it’s no holds barred,” Clarke said, explaining that customer feedback and real-world experience of the device says more about its therapeutic benefit than a controlled clinical study might.
The company does not have clinical data to support claims of medication reduction or surgery avoidance associated with the MedCline, however patient testimonials posted on the company’s Facebook page and website suggest that some patients who use the device have been able to reduce their medication use and, in some cases, even avoid surgery.