Abdominal suturing tests show that the Switch® facilitates the use of ‘small bites technique in sustainable abdominal wall closure, preventing incisional hernia
- Study in The Lancet by investigators from Erasmus MC Rotterdam showing ‘small bites’ should become the standard closure technique for midline incisions
- Single patient use Switch® device allows for higher precision ‘small bites suturing of layered abdominal structures, twice as fast as the conventional technique
- Laparotomies closed with classical big-bites technique develop a hernia in 5-35% and even up to 69% in high-risk patient groups
- Cost savings of using the Switch® with small-bite approach could lead to up to $2 billion per year in the US alone
Delft, The Netherlands, June 2021 – Mellon Medical, a Dutch MedTech company focusing on the introduction of single-handed surgical suturing devices, announced to further advance the Switch® towards market introduction. The Switch® is a (single patient use) precision surgical suturing device for abdominal wall closure, ideal for enabling the ‘small bites’ technique. This will reduce the risk of complications such as post-surgery incisional hernia, resulting in improved patient outcomes and a substantial reduction of healthcare costs.
Mellon, strongly supported by its shareholders BioGeneration Ventures, OostNL, Brabant Development Company, David Pyott Trust and Thuja Capital.
Laboratories: high risk and high health costs
Laparotomies involve large incisions through the abdominal wall to gain access into the abdominal cavity – procedures such as visceral, gynecological, aortic vascular, or urological surgery. In the US, 4-5 million laparotomies are done annually. The current practice is the big-bites technique using the classical suturing tools. Clinical studies have shown that big-bites techniques relate to a high occurrence of incisional hernia of up to 35% and even up to 69% in high-risk patients, reducing the patients’ quality of life. This also has a major impact on healthcare costs. In the US alone, more than 400.000 repairs are done annually, costing more than $4 billion. And still, repair of incisional hernia has a high failure rate of over 30%, even with the use of surgical mesh. Using the Switch® with the small-bite technique would lead to cost savings of up to $2 billion per year in the US alone.
Lancet Study and preliminary abdominal suturing test in ErasmusMC leading in focus on abdominal small bite approach
A large Dutch investigator-funded double-blind, multicentre, randomized controlled trial, at surgical and gynecological departments in ten hospitals in the Netherlands, published in The Lancet in 2015, clearly showed that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia. Therefore, it should become the standard closure technique for midline incisions. Tests with the prototype were done in November 2019 at Erasmus MC in Rotterdam, the Netherlands, by two experienced surgeons. Their feedback was that the Switch’s straight needle for fascia is preferable to a curved needle and that it resulted in more regular suturing patterns. In addition, the surgeons experienced the design as ergonomic and easy to use.
Prof. dr. Hans Jeekel, MD/Ph.D., Full Professor, Erasmus MC, and co-investigator and -author of The Lancet article, commenting on the opportunities of the newly developed suturing device for abdominal wall closing:
“The use of small bites significantly reduces the occurrence of incisional hernias. Therefore, it is essential that the small-bites technique would be used by any surgeon who closes the abdomen after surgery. And if that technology can be accelerated and facilitated with a device, that could be very important.”
Jan Benschop, CEO of Mellon Medical, commenting on this new direction of the company, said:
“By working with medical specialists, and the new collaboration with the renowned and highly skilled medical technology designer Demon, being also one of our key new investors, and ergonomic experts in the development of the Switch®, Mellon will be able to reinvent suturing, bringing innovative suturing technology into the 21st century. Our mission is to improve medical procedures by providing the best possible tools. We believe our innovative platform suturing technology will improve patient outcomes and reduce overall healthcare costs.”
Conventional suturing versus The Switch®
Mellon has managed to reinvent the technique of suturing. The Switch® can be operated by lightly pinching the double-action buttons with thumb and index finger of one hand. The other hand is free to present the tissue to be sutured. This technique greatly improves the precision and efficiency of the suturing process, as surgeons no longer need to switch the needle between instruments and focus on getting control over the needle.
In the Switch®, the needle is always secured in one of the two jaws. The predictable linear path followed by the straight needle causes less motion friction, resulting in a high-quality connection of the tissue layers.
FDA approval and CE mark
Mellon expects the market introduction of the Switch® – which has been successfully tested by experienced surgeons in the Rotterdam Erasmus Medical Centre – in about 2 years, once the final development and the FDA approval process have been completed. The CE mark process runs parallel to the FDA approval procedure.
The annual worldwide sutures and suturing devices market size is estimated over $5 billion by 2026 (reference: Global Surgical Sutures Market 2021-Marketinsights-Maia Research).
Mellon Medical was founded with the objective of developing a new medical device that enables more efficient and effective suturing of both tubular and layered structures. Having long been aware of the complexity of suturing such tissue through many years of surgical practice, Mellon strongly believed that suturing with one hand could improve the procedure and therefore patient outcome.
Mellon’s Switch® was designed to accomplish the most accurate suturing in half the time. Its main competitor is classical suturing, done with a needle holder and forceps, as both techniques use a suture thread to ligate the tissue.
Thanks to Mellon’s patent portfolio, consisting of four patent applications, the company has effectively protected both its current technology, as well as its possible future diversification, allowing for the scalability of Mellon’s product offering.
For further inquiries, please contact:
Jan Benschop, CEO
Delft, the Netherlands