A biodegradable, 3D-printed pigtail stent for gastric leaks can be a valuable teaching tool for medical 3D-printed device entrepreneurs. This mental exercise with a recent novel design shows the reimbursement logic every device team should learn before they fall too deep in love with their own inventions. Medical device reimbursement in the United States often rewards factors other than clinical performance. A recent preprint makes the gap easy to see. It describes BRIDGE, a 3D-printed, biodegradable double-pigtail stent for draining gastric leaks after sleeve gastrectomy. The design is clever. Its lattice mid-section is built from a triply periodic minimal surface (TPMS). It bends around a radius that is roughly seven times tighter than that of a commercial biliary stent, without kinking. It drains about twice the fluid. And because it is printed from a biodegradable resin, it is designed to dissolve on its own rather than be removed during a second endoscopy.¹

So it is better.

However, the question that decides whether it becomes a product is a different one. What gets paid, and to whom? In the United States, clinical superiority and payment are only loosely related. The space between them is where most device companies get their education. An endoscopic leak drain is a good place to learn the lesson. Here are some of the steps to reason it out.

What the procedure pays today

Start with the problem the device treats, because the money follows the problem. Gastric leak occurs in 1% to 3% of primary sleeve gastrectomies and as many as 10% of revisions. It is the complication surgeons fear most. It turns a routine bariatric case into weeks of drainage, repeat procedures, and sometimes an intensive-care stay. The mainstay treatment is endoscopic internal drainage with double-pigtail stents. It closes most leaks. And it does so with stents designed for the bile duct and pressed into service off-label because nothing better is available.¹

Here is the first thing to absorb. Medicare pays the physician for the procedure, not for the stent.

And the procedure it covers depends on how the pigtail is placed. If an interventional radiologist places it through the skin into the collection, the claim is a percutaneous drainage code with its own predictable payment. If an endoscopist deploys it transluminally across the leak, the claim is coded as an upper-GI endoscopy code. That is the route BRIDGE is built for, and the coding gets murkier. The closest listed option, 43240, is written for draining a pseudocyst.² A post-surgical leak is not a pseudocyst. So many of these cases land on 43499, the “unlisted” upper-GI code a payer reviews and prices by hand.³ That invites delay and denial.

Either way, the stent itself is a supply. Its cost is buried inside the facility payment for the procedure. That is an outpatient APC. Or, for the septic inpatients, most of these are DRGs. A percutaneous drain runs a hospital somewhere between $28 and $55 apiece.⁶ A fancier printed device might cost more to make. But the hospital’s payment does not move to cover it. Build a better version of a bundled supply, and it inherits the price of the thing it replaced.

(See Glossary section for all abbreviations.)

What actually changes the payment

If a superior device does not automatically earn more, what does? Three things, from the flimsiest to the most durable.

The first is a temporary top-up.

Medicare will pay a little extra for a while. Outpatient, this comes through pass-through. Inpatient, it comes through the New Technology Add-on Payment (NTAP). The price of entry is the same for both. The device has to be new. It has to be expensive enough that the existing bundle can’t absorb it. And the hard part is that it has to be a substantial clinical improvement over what’s already in use.⁴ There is a gate hidden inside the word “new.” CMS also asks whether the device is already adequately described by an existing payment category. This is where a genuinely new design earns its keep. A better plastic pigtail looks like every other pigtail and gets waved into the bundle, but a device that dissolves in the body is harder to call the same thing you already pay for. Even after clearing the bar, the money is just temporary. Pass-through runs up to three years. Then the device drops back into the bundle.⁵

The second is a dedicated device code. A new CPT code is the more durable move. But it follows a new service, not a better instrument. That is the quiet opportunity here. Endoscopic internal drainage of a leak has no code that actually fits it. That is why the field is stuck between a pseudocyst analogy and an unlisted code. A device built specifically for the procedure gives the device maker something to hang a Category III code on. That is the emerging-technology tier. It records that the procedure is happening. With utilization and outcomes data behind it, that code can grow into a paying Category I code. The process is slow, measured in years. Like it or not, it will help the competitors too. It is the only lever that fixes billing for the whole field rather than renting a payment for one product.

The third isn’t a billing lever. For a device like this, it is often the one that matters most. A leak admission is expensive and long. Under a fixed DRG, the hospital swallows every extra day and every repeat scope. A device that empties the cavity faster, keeps the patient off a second or third procedure, or shortens the septic stay puts real money back in the hospital’s pocket. No code change required, but value is added. This lever sells on a spreadsheet the hospital keeps.

Which features carry weight

Sorting BRIDGE’s advantages against the clinical-improvement test is a useful exercise, but it doesn’t weigh them equally.

Biodegradability can be a strong one. Today, a patient undergoes roughly three endoscopies over about eight weeks. A stent designed to dissolve in six to eight weeks eliminates the need for a retrieval trip entirely.1 “One fewer procedure per patient” is a true improvement, and it is easy to measure.

That said, there is a potential wrinkle to the economics. The retrieval the new device deletes is a procedure the endoscopist currently bills. Innovation improves the system’s economics, partly by reducing a provider’s revenue. That is exactly why early adopters will be integrated systems and bundled-payment programs, not fee-for-service proceduralists. (Remember what Charlie Munger’s theory behind “incentives” is.) Less migration comes next. Every stent that stays put is a retrieval, and a failed-drainage rescue that the hospital doesn’t have to do. Better flow and easier placement are real but soft. “Easier for the endoscopist” isn’t something Medicare rewards unless it results in a shorter procedure or fewer complications that can be easily measured.

There is a catch a reviewer will find first and can sink the thesis. Once a device can’t be removed, its degradation timing is its safety profile. Dissolve too early, and it fails while the leak is still open. Linger too long, and it becomes the source of granulation, obstruction, or a fragment that drifts somewhere you can no longer reach it. So the elegant “no removal” story and the “less migration” story have to be proven together. The evidence that carries weight is the degradation curve’s reliability. Not just its average, but how much it varies across real patients. That is where the clinical dollars go. It is also where a printed polymer either earns trust or loses it. The industry has learned expensive lessons on resorbable stents very recently. 8

The 3D printing angle

The 3D printing that enables the lattice and patient-specific fit does not qualify for a reimbursement category. Nobody pays more because a device was printed. What changes with 3D printing is the regulatory road. A biodegradable, architected, possibly patient-matched implant probably won’t slide through on a 510(k) predicate. It is more likely to face a de novo or PMA review. That costs time and money. And, awkwardly, it also strengthens the payment case. Devices that clear the more rigorous regulatory pathways have historically fared better when they request a separate payment from CMS. The higher bar and the better lane turn out to be the same door.

Conclusion

For a device like this, here are some potential strategies to think about. Sell to hospitals on avoided cost now, while collecting the migration, reintervention, and length-of-stay numbers. Take those numbers into a pass-through or add-on application next. Aim at a moving target. CMS has proposed requiring even breakthrough-designated devices to demonstrate substantial clinical improvement again, starting with 2028 applications.7. Finally, go earn a real code. It is the only step that changes billing for good rather than borrowing it.

The lesson under all of it: better is the price of admission, not the final payout. In US device reimbursement, the money follows evidence of a difference a patient and a payer can both feel.

Which lever is your particular improvement actually pulling?

This piece is an educational illustration of US reimbursement concepts for new medical devices, not legal, coding, or reimbursement advice. Codes, rates, and CMS policies change; confirm current figures against primary CMS sources before relying on them.

Glossary

• 510(k) FDA clearance route for a device shown to be substantially equivalent to an existing (predicate) device. The fastest, lowest-burden pathway.
• Additive manufacturing / 3D printing: Building a part layer by layer. Enables lattice geometries and patient-specific shapes that extrusion can’t produce.
• APC (Ambulatory Payment Classification): The bundled unit Medicare uses to pay hospitals for outpatient procedures. Devices used are packaged into it.
• Bundled supply: A device whose cost sits inside a broader procedure payment instead of being reimbursed on its own.
• Category I / Category III CPT codes: Category I codes are established procedure codes with set payments. Category III codes are temporary for emerging services that track usage before potentially becoming Category I.
• CMS (Centers for Medicare & Medicaid Services): The federal agency that sets Medicare payment rules and rates.
• CPT (Current Procedural Terminology): The AMA code set that identifies procedures for billing. The code, not the device, usually drives payment.
• De novo FDA: pathway for novel low-to-moderate-risk devices with no predicate, creating a new device classification.
• DPS (double-pigtail stent): A drainage stent with curled ends that anchor it. Used off-label for endoscopic internal drainage of leaks.
• DRG (Diagnosis-Related Group): The bundled unit for an inpatient stay. The hospital receives a fixed amount regardless of individual supply costs.
• EGD (esophagogastroduodenoscopy): Upper-GI endoscopy. The procedure family under which transluminal leak drainage is coded.
• EID (endoscopic internal drainage): Placing a pigtail across a leak so one end sits in the cavity and the other in the GI lumen, draining internally.
• FDA (Food and Drug Administration): The agency that authorizes devices for marketing. Clearance is separate from payment.
• HCPCS Level II (C-code): Codes that can identify a specific device for tracking or pass-through. They do not by themselves add payment.
• NTAP (New Technology Add-on Payment): A temporary inpatient add-on above the DRG for qualifying new technologies.
• Pass-through (Transitional Pass-Through, TPT): A temporary outpatient add-on (up to three years) for qualifying new devices before they are folded into the APC.
• PMA (Premarket Approval): The most rigorous FDA pathway for high-risk devices. Requires clinical evidence of safety and effectiveness.
• SCI (substantial clinical improvement): The CMS test asking whether a technology meaningfully improves diagnosis or treatment over existing options. The gate for add-on payments.
• TPMS (triply periodic minimal surface): A class of mathematically defined lattice geometries (for example, the Gyroid) used here to tune a stent’s flexibility and flow.

References

1. Phowarasoontorn P, Ko Y, Makhambetova Z, et al. Biodegradable Architected Stents for Endoscopic Internal Drainage. bioRxiv; posted May 12, 2026. doi:10.64898/2026.05.08.723751. Preprint. Not peer reviewed.
2. American Society for Gastrointestinal Endoscopy / American Medical Association. CPT code 43240: Esophagogastroduodenoscopy, flexible, transoral; with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed). ASGE EGD Coding Sheet. asge.org
3. American Gastroenterological Association. Coding Corner (Clinical Gastroenterology and Hepatology): where no specific CPT code exists for an endoscopic procedure, report the unlisted code 43499 and verify coverage with the carrier in advance. cghjournal.org
4. Centers for Medicare & Medicaid Services. New Medical Services and New Technologies (NTAP eligibility: new, costly, and a substantial clinical improvement over existing technologies). cms.gov
5. Gettysburg Healthcare Consulting. Medicare Transitional Pass-Through Payment (criteria; up to three-year duration before bundling). policypros.net
6. IndexBox. Percutaneous Drainage Catheters Price in the United States, Market Insights (2026). indexbox.io
7. Kelly S. CMS proposes repeal of add-on payment path for breakthrough devices. Healthcare Dive / MedTech Dive; April 17, 2026. healthcaredive.com
8. https://www.tctmd.com/news/fda-warns-risk-major-adverse-cardiac-events-absorb-bvs