President of Davol Inc., John Groetelaars, talks about his company's new mesh deployment device that won the blue ribbon, Best of Show award in the 2011 Excellence in Surgical Products Awards.
Surgical Products: How was the idea for the ECHO PS Position System developed? What needs were you looking to meet with this product?
John Groetelaars: Mesh placement and positioning can be one of the most challenging and time consuming steps in a laparoscopic ventral hernia repair. It’s important that mesh has adequate overlap and is centered over the hernia defect in order to minimize the chance of hernia recurrence. To aid in placement and positioning, surgeons frequently pre-place transfascial sutures prior to mesh introduction. However, surgeon feedback has been that placing and pulling up transfascial orientation sutures can be inaccurate and time consuming. Mechanical fixation can also be challenging, especially with larger pieces of mesh. Large pieces of mesh may droop down hindering visualization during fixation and the mesh may shift throughout fixation, potentially influencing accuracy of centering the mesh over the defect.
When developing the Echo PS Positioning system, Davol’s primary focus was creating a device that would deliver efficient and reproducible results in mesh placement and positioning during laparoscopic ventral hernia repair. We intended to minimize some of the challenges of placing and positioning mesh, including the time and effort involved with placing and pulling up orientation sutures. We also intended to help make positioning mesh accurate, so that appropriate overlap can be achieved on all sides when centering the mesh over the hernia defect. Lastly, we wanted the device to keep the mesh positioned against the abdominal wall for better visualization during mechanical fixation, while keeping the abdominal cavity free from additional instrumentation, potentially allowing the surgeon more freedom for efficient placement and use of the fixation device.
SP: How does this system work?
JG: The Echo PS Positioning System is a low profile balloon that comes pre-attached to either Ventralight ST (absorbable barrier) or Composix L/P (permanent barrier) Mesh. When inflated, the Echo PS Positioning System facilitates the deployment (including unrolling, positioning and placement) of the mesh during laparoscopic ventral hernia repair. The positioning system keeps the mesh open and up against the abdominal wall with no additional graspers or spreading devices needed, allowing for complete visibility and access during fixation. Upon completion of initial perimeter fixation, the balloon is deflated and quickly and completely removed from the body.
SP: What are some of the potential problems that can occur with placing and positioning mesh?
JG: Placing and positioning large pieces of mesh in the abdomen can be challenging for even the most experienced surgeons. Once introduced, mesh can be difficult to unroll in the abdomen. Ensuring that the proper side of the mesh is in the appropriate position and oriented properly may be challenging. Positioning the mesh up against the abdominal wall and accurately centering it over the defect can also be difficult to accomplish. While pre-placed transfascial sutures are commonly used to position mesh, this approach can potentially lengthen the procedure, especially when the hernia defect is large.
SP: How does the ECHO PS Position System address these problems?
JG: The Echo PS Positioning system is designed to eliminate the time and effort involved with placing and pulling up orientation sutures. Furthermore, the Echo PS technique facilitates centering the mesh over the defect, allowing for a more efficient, consistent and reproducible hernia repair. The product helps to achieve appropriate overlap on all sides of the defect.
SP: What important information should surgeons using this device keep in mind?
JG: Laparoscopic ventral hernia repair is growing in popularity as this minimally invasive approach has demonstrated positive patient outcomes. Published clinical data has shown that adequate mesh overlap is associated with decreased hernia recurrence rates. Using the Echo PS Positioning System may reduce or eliminate some of the challenges of laparoscopic ventral hernia repair and facilitate centering the mesh over the defect, resulting in a more consistent and efficient repair. The Echo PS Positioning system is available on both an absorbable barrier (Ventralight ST) and a permanent barrier (Composix L/P) mesh, allowing surgeons to use the device regardless of barrier preference.
SP: How can using the ECHO PS Position System help facilities improve patient safety, infection rates and overall efficiency?
JG: The Echo PS Positioning System has just recently launched in the US market and thus long-term clinical data is not yet available. That said, the Echo PS Positioning System facilitates a more efficient procedure by eliminating the need for placing transfascial orientation sutures and makes it easier to properly position the mesh over the defect.
Clinician feedback to date has indicated that because the Echo PS Positioning System eliminates some of the challenges of placing and positioning mesh, it may decrease procedure times and potentially minimize the learning curve for residents or surgeons new to laparoscopic ventral hernia repair. This may help an OR schedule to stay more on track throughout the day.
In addition, the Echo PS Positioning System has a unique technique that centers the mesh over the defect, helping to achieve overlap on all sides of the defect. Published clinical data has shown that adequate overlap is associated with decreased hernia recurrence rates.