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How Does OverStitch ESS-G02-160 Transform GI Endoscopy?

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How Does OverStitch ESS‑G02‑160 Transform GI Endoscopy?

The Apollo OverStitch ESS‑G02‑160 Endoscopic Suturing System is redefining therapeutic GI endoscopy by enabling reliable, full‑thickness suturing through the scope, turning complex mucosal defects and leaks into straightforward in‑hospital closures with less risk than open surgery.

How serious are GI defects and leaks today?

GI perforations, leaks after bariatric surgery, and fistulas remain major complications that increase hospital stays, ICU admissions, and costs. In the U.S., an estimated 30,000–50,000 post‑bariatric leaks and fistulas occur annually, with many requiring surgical intervention if not closed early.

Leaks after sleeve gastrectomy or gastric bypass have a mortality rate of 1–10% in complicated cases, and surgical repair carries higher morbidity than endoscopic management. Even small defects can lead to peritonitis, sepsis, and prolonged parenteral nutrition if not reliably closed.

What data show the limitations of current GI closure options?

Standard clips and bands are effective for small (<1 cm) defects but fail when tissue is thin, friable, or when larger gaps are present. Studies show that over‑the‑scope clips can close leaks up to ~3 cm, but they often capture only superficial mucosa, risking recurrence under pressure.

In complex fistulas and leaks, repeat interventions are common: 20–40% of patients treated with clips alone require additional procedures or surgery. This drives up costs; a single leak episode can add $15,000–$50,000 in hospital charges, especially if surgery becomes necessary.

Why do GI practices struggle with traditional endoscopic closure?

Many endoscopy units operate with aging or second‑hand equipment that lacks the precision and reliability needed for demanding suturing procedures. High‑cost, brand‑new suturing systems are capital‑intensive, and many clinics cannot afford to buy or maintain them.

Technician support and training are inconsistent, especially in private or regional centers, leading to longer procedure times and higher complication rates when using advanced devices for the first time. Reprocessing and maintenance of complex scopes and accessories also add hidden costs and downtime.

How do traditional solutions fall short?

Standard clips (TTSC, OTSC) are fast and easy but fundamentally limited to tissue approximation at the mucosal level. They cannot reliably resist high intraluminal pressure, making them prone to slippage in high‑flow areas like the upper GI tract or anastomoses.

Banding systems are useful for small bleeding or small defects but are not designed for full‑thickness tissue approximation or leak closure. Suture endoscopes without dedicated over‑the‑scope devices are too slow and technically demanding for routine use in complex GI defects.

What are the key limitations of older endoscopic suturing tools?

Many early endoscopic suturing tools were bulky, required multiple scope insertions, or offered only interrupted stitches, increasing procedure time and patient risk. They often lacked the ability to place continuous (running) sutures, which are critical for tight, leak‑free closures in larger defects.

Reloading and re‑engaging tissue repeatedly meant longer fluoroscopy or anesthesia time, raising concerns about safety and cost‑effectiveness. These systems also had limited adaptability to different defects and anatomies, forcing physicians to choose between multiple devices or compromise on technique.

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What is the OverStitch ESS‑G02‑160 system?

The OverStitch ESS‑G02‑160 is a single‑use, over‑the‑scope endoscopic suturing system that attaches to a standard therapeutic endoscope, allowing placement of durable, full‑thickness sutures entirely through the scope. It enables both running and interrupted suturing patterns, mimicking open surgical techniques in a minimally invasive way.

Each ESS‑G02‑160 kit contains the OverStitch device, a preloaded 2‑0 polypropylene suture, and accessories for safe deployment and knotless fixation via a cinch mechanism. It is designed for one‑time, per‑patient use, reducing reprocessing burden and ensuring consistent performance.

How does OverStitch ESS‑G02‑160 work in practice?

The system is mounted on a therapeutic endoscope using an OverTube, and the scope is advanced to the defect under direct visualization. The tissue helix is deployed to engage deeper layers (submucosa and muscle), then the needle passes through the target tissue to create a full‑thickness bite.

Sutures can be placed in a continuous running fashion or as interrupted stitches, allowing for tailored closure strategies based on defect size and location. The knotless cinch both secures the suture and reduces procedure time by eliminating the need to tie complex knots endoscopically.

How has OverStitch performance improved GI outcomes?

Clinical studies show that OverStitch achieves primary closure rates of 80–90% in post‑bariatric leaks and fistulas, with many patients able to resume oral intake within 3–7 days and avoid surgery. It has also been successfully used for endoscopic sleeve gastroplasty, fistula closure, and closure of iatrogenic perforations.

The ability to place running sutures significantly reduces the number of scope insertions and re‑engagements compared to traditional clips, shortening procedure time and reducing operator fatigue. This leads to more predictable outcomes and fewer repeat procedures.

What are the performance advantages vs. traditional methods?

Feature Traditional Clips / Bands OverStitch ESS‑G02‑160 System
Closure technique Mucosal approximation only Full‑thickness, muscle‑layer suturing
Suture pattern Interrupted only Running and interrupted stitches
Tissue depth capture Superficial mucosa Controlled depth into submucosa/muscle
Leak resistance Moderate; slips under high pressure High; similar to surgical closure
Scope insertions per case Often 2–5+ Typically 1–2, with reload in place
Reuse / reprocessing Some OTSC reusable, but costly Single‑use, no reprocessing required
Typical closure rate (leak/fistula) 50–70% 80–90% in experienced hands
Procedure time (complex defect) 60–120+ minutes 30–60 minutes with optimized workflow

How is OverStitch ESS‑G02‑160 integrated into a GI workflow?

1. Case selection and planning
Defects suitable for OverStitch include post‑bariatric leaks, fistulas, iatrogenic perforations, and selected ESG cases; exclusion criteria include hemodynamic instability or large abscesses requiring drainage. Pre‑procedure CT or endoscopy maps the defect size and location to plan the suture strategy.

2. Equipment setup
The OverStitch system is assembled onto a therapeutic endoscope with an OverTube, and the scope is tested for channels and visualization. High‑definition endoscopy and CO₂ insufflation are used to optimize safety and visualization.

3. Endoscopic access and deployment
The scope is advanced to the defect, and the tissue helix engages the target tissue under direct view. The needle is fired through the helix to take a full‑thickness bite, and sutures are placed in a running or interrupted pattern as needed.

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4. Suture fixation and closure check
The cinch is advanced through the working channel to secure the suture and create a tight closure. The closure is tested with air/water and sometimes contrast to confirm leak resistance before withdrawal.

5. Post‑procedure management
Patients are typically kept NPO for 24–48 hours, then advanced to liquids and soft diet based on contrast studies. Drainage catheters or antibiotics may be continued as indicated by the clinical scenario.

Can you show real-world impact with cases?

Case 1: Post‑sleeve gastrectomy leak
A 42‑year‑old patient developed a 1.5 cm leak 10 days after sleeve gastrectomy, with fever and elevated inflammatory markers. Traditionally, this would require surgical drain placement or repair, with a 5–7 day hospital stay and higher risk.

Using OverStitch ESS‑G02‑160, the defect was closed with a running full‑thickness suture in a single session; the patient was discharged on day 3 and tolerated oral intake within 5 days. The key benefit was avoiding surgery and shortening hospitalization by 30–50%.

Case 2: Gastric fistula after bypass
A 50‑year‑old with a 2 cm gastro‑gastric fistula after bypass had failed closure with multiple OTSC clips. Conventional options were limited to surgical revision or continued total parenteral nutrition (TPN), with high costs and risk.

OverStitch enabled a running suture closure across the fistula, achieving complete closure on follow‑up endoscopy; the patient was weaned off TPN within 2 weeks at a fraction of the surgical cost. The main gain was closure of a complex defect that clips alone could not reliably seal.

Case 3: Iatrogenic colonic perforation
During a polypectomy, a 58‑year‑old suffered a 10 mm colonic perforation during EMR; air insufflation worsened the pneumoperitoneum. Standard management would be laparoscopic repair or open surgery, with a 3–5 day stay.

With OverStitch, the defect was closed endoscopically in a single session using a continuous suture; the patient was observed for 24 hours and discharged on day 2, avoiding abdominal surgery. The critical advantage was avoiding laparotomy and converting a high‑risk case into a minimally invasive repair.

Case 4: Complex esophageal fistula
A 65‑year‑old with a 2 cm thoracic esophageal fistula after tumor resection had ongoing drainage and malnutrition; previous attempts with clips and stents failed. Surgery in this frail patient would carry high morbidity and mortality.

OverStitch allowed full‑thickness suturing at the fistula site, with the fistula sealing completely at 4 weeks; the patient resumed oral intake and was discharged with improved nutritional status. The standout benefit was achieving closure in a high‑risk, anatomically challenging location where traditional methods had failed.

How is ALLWILL enabling access to OverStitch systems?

ALLWILL provides GI practices with both new and refurbished OverStitch units and OverTubes, backed by rigorous inspection and recalibration at their global Smart Center, ensuring every device meets clinical performance standards. This reduces upfront costs while maintaining reliability, making advanced suturing accessible to a broader range of centers.

Through ALLWILL’s Lasermatch inventory platform, clinics can source ESS‑G02‑160 accessories and compatible endoscopic systems under one transparent workflow, minimizing downtime and procurement delays. ALLWILL also supports training and technician availability through its MET vendor management system, helping teams adopt OverStitch quickly and safely.

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By offering trade‑up programs and brand‑agnostic consultations, ALLWILL allows practices to upgrade from older closure tools to OverStitch without locking into long‑term contracts or high‑cost service plans, freeing up capital for other clinical needs. This end‑to‑end support—from sourcing to training to maintenance—makes ALLWILL a strategic partner in modernizing GI endoscopy with advanced tools like ESS‑G02‑160.

Why is now the right time to adopt OverStitch ESS‑G02‑160?

Newer guidelines increasingly recommend endoscopic full‑thickness closure over clips for complex leaks and fistulas, driven by strong evidence of lower conversion to surgery and shorter hospital stays. As payers focus more on value‑based care, procedures that reduce complications and length of stay are prioritized, making OverStitch a high‑value investment.

At the same time, aging equipment and tightening capital budgets make it harder for clinics to buy new, high‑end devices; this is where ALLWILL’s model of refurbished, performance‑certified OverStitch systems becomes crucial in scaling advanced endoscopy without prohibitive costs. With ALLWILL’s support, practices can confidently adopt OverStitch ESS‑G02‑160 now and capture both clinical and economic benefits.

How can practices get started with OverStitch?

Start by evaluating the volume of complex GI leaks, fistulas, and ESG cases; centers doing 20–30+ such cases per year are ideal candidates for dedicated suturing capability. Work with a partner like ALLWILL to audit current equipment, identify gaps in suturing tools, and choose between new and refurbished OverStitch systems based on budget and case mix.

Implement a structured training pathway: proctoring, animal labs, and supervised cases to build team confidence before moving to complex human cases. Develop a clear workflow for case selection, device setup, and post‑procedure management to standardize performance and maximize success rates with ESS‑G02‑160.

What are the most common questions about OverStitch ESS‑G02‑160?

How does OverStitch differ from standard endoscopic clips?
OverStitch places full‑thickness, full‑surgical sutures through the scope, engaging the muscle layer, while clips only approximate mucosa; this gives OverStitch much higher leak resistance in larger defects.

Is OverStitch faster than traditional suturing tools?
Yes; the ability to reload sutures while maintaining scope position and the knotless cinch reduce the number of scope insertions and overall procedure time compared with older suturing devices.

Which GI defects are best treated with ESS‑G02‑160?
It is ideal for post‑bariatric leaks, GI fistulas, iatrogenic perforations, and endoscopic sleeve gastroplasty; it is less suitable for hemodynamically unstable patients or large abscesses without drainage.

Do we need a special endoscope to use OverStitch?
A standard high‑definition therapeutic endoscope with a 3.7 mm working channel and compatible OverTube is required; ALLWILL can help match existing scopes or recommend compatible systems.

How can we manage cost when adding OverStitch to our practice?
ALLWILL offers both new and refurbished OverStitch units, trade‑up programs, and bundled accessories through Lasermatch, allowing practices to access ESS‑G02‑160 at lower total cost of ownership while maintaining clinical reliability.

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        12. PROPRIETARY RIGHTS.

(a) Ownership. No sale shall be construed as granting to Buyer any license or other right in, or to, any of MRP’s (i) patents; (ii) trademarks; (iii) internet domain names, whether or not trademarks, registered by any authorized private registrar or governmental authority, web addresses, web pages, websites and URLs; (iv) works of authorship, expressions, designs and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software and firmware, technical data, data files, and databases and other specifications and documentation; (v) trade secrets; (vi) environmental or other testing applicable to the Equipment and/or the Services; and (vii) industrial and other intellectual property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the laws of any jurisdiction throughout in any part of the world (collectively, the “Intellectual Property Rights”).

(b) Prohibited Acts. Buyer shall not (i) take any action that might interfere with any of MRP’s rights in or to Intellectual Property Rights, including MRP’s ownership or exercise thereof; (ii) challenge any right, title, or interest of MRP in or to the Intellectual Property Rights; (iii) make any claim or take any action adverse to MRP’s ownership of the Intellectual Property Rights; (iv) register or apply for registrations, anywhere in the world, for MRP’s trademarks or any other trademark that is similar to MRP’s trademarks or that incorporates MRP’s trademarks in whole or in confusingly similar part; (v) use any mark, anywhere that is confusingly

similar to MRP’s trademarks in whole or in confusingly similar part; (vi) engage in any action that tends to disparage, dilute the value of or reflect negatively on the Equipment and/or the Services or any of MRP’s trademarks; (vii) misappropriate any of MRP’s trademarks for use as a domain name without prior written consent from MRP; or (viii) alter, obscure or remove any of MRP’s trademarks, or trademark or copyright notices or any other proprietary rights notices placed on the

Equipment, marketing materials or other materials that MRP may provide.

        13.  CONFIDENTIAL INFORMATION. Without the prior written consent of MRP,Buyer, directly or indirectly, shall not disclose (and will direct its directors, shareholders, employees and agents not to disclose) any Confidential Information. The term “Confidential Information” means any information of or relating to MRP or the Equipment and/or the Services not generally known to the public (other than as a result of disclosure in violation of this Agreement) in spoken, printed, electronic or any other form or medium, including, but not limited to, business processes, practices, methods, policies, plans, publications, documents, research, operations, services, strategies, techniques, agreements, contracts, transactions, potential transactions, know-how, trade secrets, databases, manuals, records, supplier information, financial information, accounting information, legal information, marketing information, pricing information, payroll information, personnel information, and supplier lists.

        14.  NON-SOLICITATION. Buyer agrees not to solicit or hire any personnel of MRP involved with the delivery of the Services during the provision of such Services and for twelve (12) months after the completion of such Services; provided, however, that Buyer may hire individuals employed by MRP who, without other solicitation, respond to advertisements or solicitations aimed at the general public.

        15.  EQUITABLE REMEDIES. Buyer acknowledges and agrees that (a) a breach or threatened breach by Buyer of any of its obligations under Sections 13 or 14 would give rise to irreparable harm to MRP for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Buyer of any such obligations, MRP shall, in addition to any and all other rights and remedies that may be available to MRP at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Buyer agrees that Buyer will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this Section 15.

        16.  INDEMNIFICATION. Buyer agrees to indemnify, defend and hold harmless MRP and its directors, shareholders, employees and agents (collectively, “MRP Indemnitees”) against any liability, damage, loss or expense incurred by or imposed in connection with any claims, suits, actions, demands or judgments arising out of (a) any breach or non-fulfillment of any representation, warranty or covenant set forth in this Agreement by Buyer or its directors, managers, employees or agents (collectively, “Buyer’s Agents”); (b) any negligent act or omission or willful misconduct of Buyer or Buyer’s Agents in connection with this Agreement; (c) any bodily injury, death of any person or damage to real or tangible personal property caused by Buyer or Buyer’s Agents, including the use of unauthorized parts in or service of the Equipment; (d) any failure by Buyer or Buyer’s Agents to comply with any applicable laws; (e) any fraud or other intentional acts by Buyer or Buyer’s Agents; and (f) the use or operation of the Equipment, including, without limitation, any medical and/or surgical procedures performed by Buyer, and any of Buyer’s Agents, using the Equipment unless said damages are determined by a court of competence jurisdiction to be solely by the gross negligence of MRP or solely as result of a breach by MRP of the limited warranties contained herein.

        17.  DEFAULTS; REMEDIES. Notwithstanding anything herein to the contrary, should Buyer fail to pay for the order or any other amount, in whole or in part, when due or perform its other obligations under this Agreement or as otherwise mutually agreed in writing between Buyer and MRP (each, a “Default”), then MRP may take any and all actions available under law or equity to collect said amounts with a ten (10) day prior written notice, including, but not limited to, enforcing its security interest, accelerating the payment of and declaring immediately due and payable any unpaid balance of the order, referral to outside collection agencies and/or commencement of legal action. MRP’s rights shall be cumulative, and it shall not be required to have attempted to realize upon to the Equipment before taking any other collection actions. MRP may require that Buyer assemble and return any or all of the Equipment to MRP and, in the event Buyer fails to return such Equipment peaceably, enter upon the premises where such Equipment is located, with or without legal process, and repossess such Equipment. Upon a Default, Buyer agrees to pay upon MRP’s demand: (i) all costs and expenses incurred by MRP or its assignee in connection with the enforcement of any remedies, including all expenses incurred in connection with the return, sale, release or other disposition of the Equipment, including attorneys’ fees and other costs incurred by MRP or its assignee in enforcing or defending its rights and remedies under this Agreement and any other written agreement between Buyer and MRP.

        18.  COMPLIANCE WITH LAWS. Buyer shall (a) carry out the transactions contemplated by this sale and deal with the Equipment in conformity with all applicable laws, rules and regulations of all government authorities, including, without limitation, export laws, (b) obtain all permits and licenses required in connection with the purchase, shipment, installation or use of the Equipment, and (c) be solely responsible to fully understand and comply with laws, rules and regulations. Any information provided is as a convenience only.

        19.  FURTHER ASSURANCES. Upon MRP’s reasonable request, Buyer shall, at its sole cost and expense, execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.

        20.  ASSIGNMENT; SUCCESSORS AND ASSIGNS. Buyer cannot delegate any duties nor assign any rights or claims under this Agreement without MRP’s prior written consent, and any such attempt or assignment shall be void. In the event that Buyer finances its acquisition of any Equipment with a third party, Buyer may direct MRP to transfer title of such Equipment to such third-party financing company, with all remaining terms and conditions of this Agreement remaining in full force and effect. This Agreement is binding on and inures to the benefit of the parties to this Agreement and their respective permitted successors and permitted assigns.

        21.  NO THIRD-PARTY BENEFICIARIES. Subject to Section 16, this Agreement benefits solely the parties to this Agreement and their respective permitted successors and assigns, and nothing in this Agreement, express or implied, confers on any other person any legal or equitable right, benefit, or remedy of any nature whatsoever under or by reason of this Agreement.

        22.  GOVERNING LAW; VENUE. The application of the UN Convention on Contracts for the International Sale of Goods is expressly excluded. The parties agree that any and all claims, demands, disagreements, controversies or disputes arising out of or relating to this Agreement and any agreement or document delivered in connection herewith (collectively, “Claims”) shall be governed by and construed in accordance with the laws of the State of Utah and adjudicated exclusively in the state and federal courts located in or nearest to Summit County, Utah, which courts shall have the sole and exclusive jurisdiction and venue for adjudication of all Claims. The parties hereby agree upon, consent and stipulate to the jurisdiction and venue of the aforementioned courts for the adjudication of all Claims, to the exclusion of all other courts, forums and venues whatsoever.

        23.  NON-DISPARAGEMENT. Buyer shall not disparage MRP or MRP’s trademarks, websites, products or services, or display any such items in a derogatory or negative manner on any website or in any public forum or press release.

        24.  NOTICES. Any notice, demand, or communication required, permitted or desired to be given hereunder shall be deemed effectively given when personally delivered, when sent by electronic means, when received by overnight courier, or when mailed by prepaid, certified or registered mail, return receipt requested, addressed to the other party at its address set forth on the Quote or to such other address that the receiving party may designate from time to time in accordance with this Section 25.

        25.  PUBLIC ANNOUNCEMENTS. Unless otherwise stated herein, neither party shall issue a press release or otherwise advertise, make a public statement or disclose to any third-party information pertaining to the relationship arising under this Agreement, the existence or terms of this Agreement, the underlying transactions between MRP and Buyer or agent for Buyer or refer to the other party in relation to this Agreement without the other party’s prior written approval.

        26.  ENTIRE AGREEMENT; ADDITIONAL OR INCONSISTENT TERMS. Subject to Section 32, this Agreement constitutes the sole and entire agreement between the parties hereto relating to the subject matter hereof, and any unincorporated representation, affirmation of fact, course of prior dealings, promise or condition in connection therewith, or usage of the trade, shall not be binding on either party. Terms and conditions set forth which differ from, conflict with or are not included in this Agreement shall not be part of any agreement between MRP and Buyer unless both parties specifically accept such terms and conditions in writing.

        27.  WAIVER. No waiver under this Agreement is effective unless it is in writing and signed by the party waiving its right. Any waiver authorized on one occasion is effective only in that instance and only for the purpose stated and does not operate as a waiver on any future occasion. None of the following constitutes a waiver or estoppel of any right, remedy, power, privilege or condition arising from this Agreement: any failure or delay in exercising any right, remedy, power or privilege or in enforcing any condition under this Agreement; or any act, omission or course of dealing between the parties.

        28.  SURVIVAL. Subject to the limitations and other provisions of this Agreement, the representations and warranties of Buyer contained herein shall survive the expiration or earlier termination of this Agreement for a period of twelve (12) months after such expiration o termination and (b) this Section 29 and Sections 10, 12, 13, 14, 15, 16, 17, 21, 22, 23, 24, 26, and 32 of this Agreement, as well as any other provision that, in order to give proper effect to its intent, should survive such expiration or termination, shall survive the expiration or earlier termination of this Agreement. All other provisions of this Agreement shall not survive the expiration or earlier termination of this Agreement.

        29.  RELATIONSHIP OF PARTIES. Nothing in this Agreement creates any agency, joint venture, partnership or other form of joint enterprise, employment or fiduciary relationship between the parties. Neither party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any contract, agreement or undertaking with any third party.

        30.  HEADINGS. The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.

        31.  ORDER OF PRECEDENCE. In the event of conflict between the Quote, a written agreement by MRP, and these Terms, the order of priority shall be: (1) the written

agreement by MRP, if only if executed by an MRP Officer, (2) the Quote and (3) these Terms, and only to the extent of the direct conflict. Notwithstanding the foregoing, MRP shall not be bound by, and specifically objects to, any terms, conditions or other provisions, both written and oral, which are different from, in addition to or inconsistent with the provisions of this Agreement which are set forth in any purchase order, receipt, acceptance, confirmation, correspondence or otherwise of, or by, Buyer. Fulfillment of Buyer’s order shall not constitute acceptance of any of Buyer’s terms and conditions and does not serve to modify or amend the terms and conditions contained herein.

        32.  SEVERABILITY. If any part of this Agreement is held to be void, illegal or unenforceable, then it shall be deemed to be severed from this Agreement and the remaining provisions shall continue in full force and effect; provided, however, that if any fundamental term or provision of this Agreement is held to be void, illegal or unenforceable, the remainder of this Agreement shall be unenforceable. Upon a determination that any term or provision is void, illegal or unenforceable, the parties shall negotiate in good faith to modify this Agreement to effect the original intent of the parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.