Anastomotic leaks are one of the leading causes of mortality in gastrointestinal surgeries and staple-line integrity is an essential treatment option to prevent the complications associated with the leaks. Ever since the development of surgical stapler technology for secure intestinal anastomosis, continuous efforts have been made to advance standardizing methods and devise an optimized stapling solution to reduce leaks without compromising perfusion. Most of the complications faced by patients after staple anastomoses including bleeding, leaking, and discomfort, mainly due to malfunctions such as inappropriate device choices, difficulty with firing, and manual errors. While many modifications have been introduced in the staple design and configuration, a little progress has been made in circular stapler functionality. Recently, Ethicon released Echelon Circular powered surgical stapler, specifically designed to deliver optimal compression for a secure anastomosis. Incorporating two Ethicon’s powerful proprietary technologies, the circular stapler addresses the device-to-tissue and device-to-user interaction to enable better prevention against leaks. 

The 3D Stapling Technology evenly distributes compression throughout anastomosis and thus reduces potential leak paths, resulting in 61% fewer leaks at the staple line. Another proprietary technology inculcated in the surgical stapler device is Gripping Surface Technology (GST), which facilitates precise compression only where tissue preparation is required for staple formation. The GST technology also provides gentler handling with a 33% reduction in compressive forces on tissue and is supposedly more tender on the tissue being stapled. The Powered firing platform enables 33% lesser movement at the distal tip to enhance stability and reduces the force to fire by 97% with push-button firing. The powered firing platform is designed to minimize variation in applications and standardize operations across different users with varying needs. Design modification in circular stapling technology reduces unwanted movements at the anastomosis site, which significantly reduces the rate of technical errors and results in better clinical outcomes.

Echelon Circular stapler is touted as the industry’s first powered stapler that has been developed to address anastomotic leaking associated with colorectal, gastric, and thoracic surgery. When compared with Ethicon’s main competitor, Medtronic DST series EEA Stapler, the device reduces the amount of movement at the tip during the firing of staples due to its high-powered triggers that allow surgeons to function by just gently pressing it. Thus, the Echelon circular powered stapler produces a safer and more reproducible anastomosis than its Medtronic counterpart. The integration of 3D stapling technology with gripping surface technology allows the creation of air-tight and fluid-tight anastomoses that makes a lot of difference when it comes to reducing complications and improving patient outcomes. 

One of the significant factors responsible for misfire or manual errors with the use of manual circular staplers was the amount of force generated to perform anastomosis, which resulted in unwanted movements at the site. The application of conventional stapling devices is linked to cause microvascular trauma and compromise anastomosis healing. On the contrary, the ergonomic design of the circular stapler device allows the staple to be fired conveniently irrespective of the surgeon’s hand strength or size, which enhances stapling head stability. Reducing reliance on the surgeon for generating the force leads to a more consistent compression of the stapler onto the tissues, thus the device minimizes the average compressive force experienced by the target tissue when compared with a manual stapler.

Other Circular Stapler Alternatives

Medtronic Tri-Staple EEA Circular Stapler

Medtronic EEA circular stapler with Tri-Staple technology is designed for higher security with the potential for greater prefusion. The novel technology comprises a sloped cartridge face that provides less stress on the tissue and offers consistent performance over a broad range of thicknesses. The device is intended for use in colorectal procedures during anastomosis to avoid any leaks. The Tri-Staple technology ensures greater perfusion into the staple line with different height staples and graduated compression profiles.

Grena Disposable Circular Stapler 

The reusable circular stapler is widely used in general surgery, thoracic surgery, colorectal surgery for performing anastomoses. The compact stapler utilizes titanium staples assembled in two concentric rings containing disposable cartridges. The disposable cartridges are available in four diameters and can be easily operated with a trigger handle. The modern design of the circular stapler ensures the safety of the patients as it minimizes the risk of leaks. The device features a non-detachable construction with an open casing that allows cleaning without disassembling. The safety lock in the device helps to prevent unwitting trigger squeeze and every single cartridge comes with a disposable anvil for convenience. 

Linear Surgical Stapler-ECHELON Flex Powered Vascular Stapler 

Ethicon Echelon Flex Powered Vascular Stapler is designed to provide enhanced precision, better visibility, and stability for critical vessel transections. Device powered with GST offers a better way to handle a broad range of tissue thicknesses and deliver four times less tissue slippage. The one-handed and easy-to-use platform aids in proper staple formation, essential to attain a leak-resistant staple line. Optimal staple formation even in thick tissues helps to exude fluid from targeted tissue before firing. The device allows a surgeon to stay focused on the surgical intervention without interruption in order to facilitate precise placement of anvil. The compact size of the trans-section device makes it accessible to critical vascular sutures and allows minimally invasive approaches for the treatment of more central tumors. The powered vascular stapler enables precise placement on fragile pulmonary vessels by providing a broad range of approach angles within the limits of intercostal space. 

Medtronic’s Signia Stapling System is a tough competitor to Echelon Flex powered vascular stapler. The Medtronic counterpart is a new and advanced surgical stapler that detects the tissue being worked upon and adjusts its speed to create optimal staple lines. The proprietary Adaptive Firing technology of Medtronic incorporated in the novel surgical staples enables the physician to measure the force required to penetrate the tissue.

Limitations of Surgical Stapler 

Every year, thousands of patients report serious surgical stapler complications, often due to malfunctioning devices. Surgical stapler malfunctions such as malformation of staples, use of improper stapler size, or misfiring can lead to complications such as bleeding, tissue damage, increased risk of cancer, or even death. Since surgical staplers are used in place of sutures for faster and less accurate closing of incisions, any malfunction can cause serious damage to the surrounding tissues or organs. Even manufacturers have recalled multiple surgical staplers due to patient injuries resulting from defects in the past few years.

Conclusion 

The mechanical medical devices complement the advancements in medical procedures and modification of existing ones. Burgeoning demand for laparoscopic surgeries has led to a greater reliance on surgical staples. Billions of surgical staples are sold every year and the revenues are anticipated to double up by 2026. Two of the top MedTech companies, Ethicon (a subsidiary of Johnson and Johnson) and Medtronic account for nearly 80% of the global surgical staple market. However, a rising number of complications associated with the application of surgical staples can hinder the market growth of surgical staples during the forecast period. 

According to TechSci research report on “India Minimally Invasive Surgical Instruments Market By Type (Endoscopes, Laparoscopy Instruments, Electrosurgery, Others), By Application (Abdominal, Neurology, ENT and Cancer, etc.), By End-User (Hospitals, Surgical Centers), By Region, Competition, Forecast & Opportunities, FY2026 FY2026”, India minimally invasive surgical instruments market is anticipated to grow at a formidable CAGR and surpass a market value of USD630 million by 2026. The growth can be attributed to the increase in geriatric population and the needs for minimally invasive procedures to minimize the appearance of scars. Besides, medical advancements in the healthcare sector are expected to boost the growth of minimally invasive surgical instruments during the forecast period.

According to another TechSci Research report on “Europe Minimally Invasive Surgical Instruments Market By Instrument (Endoscopes, Laparoscopy Access Instruments, Laparoscopy Handheld Instruments, Robotic Assisted Surgical Systems, Electrosurgery, Visualization and Monitoring System), By Type (Endoscopy, Laparoscopy, Robotics), By Application (Gynecology, Orthopedic Surgery, Respiratory, Oncology, Gastrointestinal, Urology, Cardiology, Others), By End-User (Hospitals, Surgical Centers, Others), By Country, Forecast & Opportunities, 2025”, Europe minimally invasive surgical instruments is anticipated to register a significant growth during the forecast period. Rising number of lifestyle-related disorders and increasing geriatric population are fueling the growth of Europe minimally invasive surgical instruments. Moreover, low cost and less pain associated with minimally invasive procedures than conventional surgeries are further boosting the demand for surgical instruments in the region.