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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

Ethicon Launches New Echelon+ Stapler with GST Reloads

Ethicon Launches New Echelon+ Stapler with GST Reloads

Ethicon, part of the Johnson & Johnson Medical Devices Companies has announced the global launch of the ECHELON+ Stapler with GST Reloads, a new powered surgical stapler designed to increase staple line security and reduce complications through more uniform tissue compression and better staple formation, even in challenging situations. [1,2,3]

The ECHELON+ Stapler is the latest addition to the company’s ECHELON Powered Stapler portfolio. The portfolio has been associated with improved clinical and economic outcomes including fewer bleeding complications, reduced hospital costs and improved efficiency across, procedures, patient populations and countries in large-scale retrospective studies.[4,5,6,7,8]

Several innovative design features distinguish the new device from previous staplers including a reengineered ECHELON+ Anvil, that with Gripping Surface Technology (GST) Reloads, is designed for more uniform compression to better capture and form staples, as well as a new motor with Dynamic Firing, which optimizes firing speed in thick tissue to enhance compression and improve audible feedback. In recent benchtop testing, the ECHELON+ Stapler outperformed Medtronic’s Signia and EndoGIA Staplers with Tri-Staple Reloads providing better staple formation and reducing leaks at the staple line.[2,9]

“The ECHELON+ Stapler is a meaningful innovation that addresses a key concern of bariatric surgeons, improving staple line security to help reduce complications,” said Joseph Northup, MD, medical director, Premier Weight Loss Solutions*.

Despite recent advances in surgical stapling technology, perioperative complications persist across specialties. Complications are driven primarily by postoperative anastomotic leaks and bleeding-related complications which may occur in up to 12% of colorectal resections and in 2% to 10% of lobectomies, respectively.[11,12]

“The launch of the ECHELON+ Stapler with GST Reloads is another milestone in our continuing commitment to evidence-based innovation that can enhance the surgeon’s experience, improve patient outcomes and deliver meaningful clinical and economic value. Our goal is to always elevate the standard of surgical care,” said Tom O’Brien, Worldwide Endomechanical President, Ethicon.

* Joseph Northup, MD is a paid consultant for Ethicon

  1. Benchtop testing in porcine tissue ≤ 52mmHg (Double the 26mmHG average pressure experienced during intra-operative leak test), comparing Ethicon ECHELON+ Stapler PSEE60A with GST Reloads GST60B to Medtronic Signia Stapler with Tri-Staple Reloads EGIA60AMT and Medtronic EndoGIA with Tri-Staple Reloads EGIA60AMT. Cumulative number of leaked tests (14/30), (23/30), (25/30) respectively, n=30 p < 0.05. (150356-200818).
  2. Benchtop testing in 3.2mm synthetic tissue comparing staple line compression between ECHELON+ Stapler with GST Reloads (PSEE60A, GST60B,GST60G) to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple™ Reloads (EGIA60AMT). Resulting in a statistically significant compression uniformity, p<0.05. (155751-201014).
  3. Benchtop testing in 3.3mm and 4.0mm porcine tissue comparing malformed staples between ECHELON+ Stapler with GST Reloads (GST60B,GST60T) to Medtronic Signia™ Stapler with Tri-Staple™ Reloads (EGIA60AMT, EGIA60AXT) and Endo GIA™ with Tri-Staple™ Reloads (EGIA60AMT, EGIA60AXT). Percentage malformed results: 1.14% vs 4.28%, p < 0.05. (151140-200826).
  4. Rawlins L, Johnson BH, Johnston SS, et al. Comparative Effectiveness Assessment of Two Powered Surgical Stapling Platforms in Laparoscopic Sleeve Gastrectomy: A Retrospective Matched Study. Medical Devices: Evidence and Research. 2020:13 195–204. doi: https://doi.org/10.2147/MDER.S256237
  5. Miller DL, Roy S, Kassis ES, et al. Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of Video-Assisted Thoracic Surgery Lobectomy Procedures: A Retrospective, Observational Study. Adv Ther. 2018 Apr 16. doi: 10.1007/s12325-018-0679-z
  6. Park SY, Kim DJ, Nam CM, et al. Clinical and Economic benefits Associated with the Use of Powered and Tissue-specific Endoscopic Staplers Among Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer. Journal of Medical Economics, doi: 10.1080/13696998.2019.1634081
  7. Roy S, Yoo A, Yadalam S, et al. Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers. Journal of Medical Economics. 2017; 20:4, 423-433, doi:10.1080/13696998.2017.1296453
  8. Tsunezuka Y, Tanaka N, Fujimori H. The Impact of Endoscopic Stapler Selection on Bleeding at the Vascular Stump in Pulmonary Artery Transection. Med Devices (Auckl). 2020;13:41-47 https://doi.org/10.2147/MDER.S240343
  9. Benchtop testing in porcine tissue ≤ 30mmHg (26mmHG average pressure experienced during intra-operative leak test), comparing Ethicon ECHELON+ Stapler PSEE60A with GST Reloads GST60B to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple Reloads EGIA60AMT, p < 0.05. (150352-200818).
  10. Koianka T, Kevin M. Martin W, et al. Identifying Important Predictors for Anastomotic Leak After Colon and Rectal Resection. Annals of Surgery. 2013; 257:108.
  11. Kent M, et al. Open, video-assisted thoracic surgery, and robotic lobectomy: review of a national database. Ann Thorac Surg. 2014;97:236-444.
  12. Based on Ethicon (2016) internal analysis of data from 26,955 lobectomy procedures captured in Premier Perspective database for the period of 2008-2014.

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