Product: EnSeal™

Amember of the Reviews in Obstetrics & Gynecology editorial board reviewed the following devices. The views of the author are personal opinions and do not necessarily represent the views of Reviews in Obstetrics & Gynecology or MedReviews®, LLC.

To submit a product for review, please contact Merilee Croft Olson (molson@medreviews.com).

• Design/Functionality Scale

  • 1 = Poor design; many deficits

  • 2 = Solid design; many deficits

  • 3 = Good design; few flaws

  • 4 = Excellent design; few flaws

  • 5 = Excellent design; flaws not apparent

• Innovation Scale

  • 1 = Nothing new

  • 2 = Small twist on standard technology

  • 3 = Major twist on standard technology

  • 4 = Significant new technology

  • 5 = Game changer

• Value Scale

  • 1 = Added cost with limited benefit

  • 2 = Added cost with some benefit

  • 3 = Added cost but significant benefit

  • 4 = Marginal added cost but significant benefit

  • 5 = Significant cost savings

• Overall Scale

  • 1 = Don’t bother

  • 2 = Niche product

  • 3 = Worth a try

  • 4 = Must try

  • 5 = Must have

Design/Functionality: 4

Innovation: 4

Value: 3

Overall Score: 4

Background

If minimally invasive surgeons were polled about areas in need of more product variety and newer technology, few would probably see a big need in the niche of laparoscopic coagulation and cutting devices. Already the space is crowded with excellent products such as Ethicon’s Harmonic™ scalpel, Covidien’s LigaSure™, or Gyrus ACMI’s PK™ Technology devices, in addition to the old standbys, Kleppinger’s forceps and scissors. With all these choices, why would the good folks at Johnson & Johnson spend money to buy SurgRx (Redwood City, CA) so that Ethicon could bring us EnSeal™?

EnSeal is really not that new. Cleared by the US Food and Drug Administration in 2003, it is rated to seal and divide arterial vessels up to 7 mm in diameter. However, the technology was owned and marketed by a smaller company, SurgRx, and EnSeal had relatively low visibility. But, low visibility and low viability are not the same and Johnson & Johnson know a good product when they see it.

Design/Functionality

On its face, EnSeal looks like all the others: pistol-grip handle, trigger, jaws, and cutting blade. However, its core technologies are really unique. Specifically, EnSeal uses something called I-Blade™ technology and a patented temperature control technology.

Anyone who has ever performed newborn circumcisions with either Gompco or Mogan clamps can appreciate the hemostatic value of crushing tissue. I-Blade technology essentially promotes very strong blood vessel-sealing burst strengths by compressing tissues with up to 7800 psi¹ while sealing them with electric energy.² The device employs an electrode with millions of nanometer-sized conductive particles embedded in a proprietary temperature-sensitive polymer that maintains tissue temperature to around 100°C. The combination of compression and fine regulation of electrical current yields vessel seals with high burst pressures and minimal thermal spread. To that end, when compared with Harmonic scalpel, LigaSure, and PKS™ cutting forceps, EnSeal demonstrated the highest mean vessel burst pressures and lowest failure rates.¹ EnSeal™ brings with it ∼1 mm of lateral thermal spread, which compares nicely to Harmonic’s ∼1 mm and LigaSure’s and PK’s ∼2 to −3 mm and 2 to 6 mm thermal spread, respectively, with nonimpedance controlled bipolar devices.

In use by the reviewer, EnSeal performed as expected: well. It quickly and hemostatically divided the infundibulopelvic ligaments when taking out ovaries, and confidently sealed and divided the uterine arteries for laparoscopic hysterectomies. In addition, it worked reasonably well as both a grasper and tissue dissector. Finally, it had minimal sticking and produced little smoke. The only real drawbacks were the somewhat ergonomically awkward handle (too narrow) and the inability to enter the vaginal cuff with the device.

Design/Functionality Score: 4

Innovation

Assessing the innovation of EnSeal is difficult if one is not a biomechanical engineer. Nonetheless, judging by what else is available in this niche, both the I-Blade technology and patented temperature control technology with the nanometer-sized particles seem like big improvements.

Innovation Score: 4

Value

Determining value for the whole family of laparoscopic coagulation and cutting devices is a difficult task. If a surgeon can safely and efficiently perform surgeries without the disposable devices-and some can-then they are all poor value. If a surgeon’s skill set limits him/her from performing the same minimally invasive procedure without the disposable devices-probably the majority-then they all represent good value. EnSeal costs about the same (retail) compared with the other devices in the field. For the space it is in, it is about average value.

Value Score: 3

Summary

I really like the EnSeal. It seals and divides vessels quickly and effectively, with confidence. I found the handle a bit uncomfortable to use ergonomically, but that is what second generations are all about. Also, it operates at some of the lowest temperatures (∼100°C)³ and thereby reduces a potential area for complications. This is a clever, versatile, well-designed device that is definitely worth a try.

Overall Score: 4