Tuesday 28 May 2013, Amsterdam
Medical Devices Strive to Fill Void in Obesity Treatment
The obesity medical device industry is expected to experience significant change in the near future, as new products come to market, older products see a decline in sales, physician adoption increases worldwide, and supporting device reimbursement is put in place. While bariatric surgery techniques have demonstrated notable improvements in safety and efficacy compared with years prior, aversion to intervention has curbed operation prevalence to less than 1% of suitable obese candidates. Moreover, diabetes indications further drive obesity medical devices sales by lowering the threshold body mass index for patients to receive implantation, and comorbidities like this can often necessitate intervention. With limited options in regards to pharmacotherapy, and near-unanimous disinclination to surgery, there is a void in treatment options, and medical devices are up for substantial adoption.
Allergan Sees Decline in Sales as New Devices Enter the Market
Whereas the obesity treatment device industry has previously been dominated by restrictive devices such as the Lap-Band (Allergan) and artificial fullness devices like the Orbera (Allergan), We now expects noteworthy adoption of malabsorption devices, including the EndoBarrier (GI Dynamics) and the soon-to-be-approved ValenTx (ValenTx), in lieu of waning interest in gastric banding and non-adjustable intragastric balloons, which have seen a suggestive decline in popularity as long-term outcomes have been published, demonstrating lack of efficacy and frequent explantations.
Improvements in Gastric Electrical Stimulation
Long-sought gastric electrical stimulation technology has advanced significantly in recent years, and two devices available on the market today, the Abiliti (IntraPace, Inc.) and DIAMOND Tantalus (MetaCure, Inc.), have been gaining physician interest internationally. Besides targeting the stomach, similar stimulation technologies have been developed for the hypothalamus, utilizing deep brain stimulation, including the NeuroSigma device, a device that is currently in preclinical testing. In addition, matching advancements in neuronal blocking technology have enabled patient-specific vagal blocking therapy, with one device already approved, the Vbloc Maestro System
(EnteroMedics), and additional products expected to enter development in the future.
Endoscopic Approaches Increasingly Popular Among Patients
Other device technologies which have undergone noteworthy improvement include endoscopic suturing and stapling tools, capable of stomach reduction surgery via transoral, incisionless access, which is increasingly popular for those strongly opposed to scars. Lastly, despite artificial fullness devices seeing a decline in sales, physicians are nonetheless excited about the development of the TransPyloric Shuttle (Baronova) and Full Sense Device (BFKW), which are both still in development, but tout next-generation technology and could potentially see widespread adoption. Numerous other devices are in developmentas the obesity medical device industry continues to grow.
What do Physicians Think?
While surgical procedure volumes remain low, the number of physicians performing these surgeries is small as well, which will drive minimally invasive device sales. Device use is ideal for treating patients who wish to lose weight, but are not morbidly obese surgical candidates.
“The incapability of surgeons to operate on the numbers that they want to will drive device sales … there is still a very important gap for patients who have a BMI between 30 and 40, because they are not surgical candidates …THERE is the endoscopic (device] field.”
Key Opinion Leader, April 2013
While device use has increased in recent years, procedures are still expensive and reimbursement is still lacking, which has been a major barrier to device adoption.
“Most people can’t afford to pay for a device out of pocket, so insurance reimbursement is a pretty critical issue with (treatment of obesity]. A lot of (device adoption] has to do with reimbursement issues.”
Key Opinion Leader, April 2013
Despite minimal reimbursement currently, GlobalData expects compensation for medical devices in the near term, as efficacy improves and long-term outcomes are published.
“When (insurers] incorporate the coverage of the surgery, they have to include all the different risks of surgery, so for the insurance companies, device use is cheaper and better. They know that, but they are not forced by law now (to provide reimbursement], so it’s a matter of time.”
Key Opinion Leader, April 2013
Open surgery and laparoscopic procedures leave scars and can be complicated with bleeding and infection; as a result, transoral, incisionless devices have seen a dramatic rise in use.
“I think there’s been some desire to have procedures that are less invasive, don’t leave scars, have lower complication rates than current procedures. I think that’s what’s driving (sales].”
Key Opinion Leader, April 2013
New device sales are driven by waning interest in currently approved devices, such as the non-adjustable intragastric balloon, which has mixed effectiveness in the long term.
“The balloon isn’t going to be effective in overly obese patients, not in this lifetime.”
Key Opinion Leader, April 2013
Next-generation technologies in gastric stimulation previously showed poor efficacy, but recent improvements in design are making these devices increasingly competitive.
“I think if we can progress with gastric stimulation, it probably is one thing that could pick up in the future. If gastric stimulation already worked, it would probably be (the preferred]
procedure…”
Key Opinion Leader, April 2013
