When the U.S. Food and Drug Administration cleared for the first time a surgical device that can be assembled and disassembled inside a patient’s body, not a lot of people noticed.
That’s probably because the manufacturer, a Cincinnati-based surgical products division of Johnson & Johnson called Ethicon Endo-Surgery, hasn’t yet launched the product — and maybe never will.
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As a result, the company isn’t too eager to publicize this new, innovative medical device. (Ethicon sent along some helpful background information on the device, the Percutaneous Surgical Set (PSS), but declined to send a photo or make anyone available for an interview.)
It was left to the FDA to issue a press release announcing that it had “allowed marketing” of the PSS, which is used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions in the abdomen.
Ethicon says it’s still deciding whether it’ll even commercialize the device. Here’s a statement from Todd Kinser, vice president of research and development.
At Ethicon Endo-Surgery, we’re always looking for ways to reduce tissue trauma during surgery, to provide better clinical outcomes for patients and to find ways to minimize the cost of healthcare. We are currently conducting a market pilot for the PSS in Europe to learn how it can support each of these priorities. As we continue to gain that learning, we expect to make a determination in the near future about whether or not we’ll introduce the PSS in the mass market in Europe and the U.S. We’ll continue to leverage the advanced technology and innovation insights from this pilot into future offerings.
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So how does the device work? The key is it’s inserted in the body like a needle, which reduces the incision size.
The surgical system includes a percutaneous shaft that’s loaded with tool attachments. It’s inserted in the body like a needle, instead of through a larger opening required by a traditional trocar, a sharply pointed, instrument that is typically used in laparoscopic surgery.
Next, according to Ethicon: “Once the shaft is through the patient’s body wall, one of three larger tool attachments are inserted through a trocar and quickly assembled in situ with the help of the loader.”
The result is a pin-size incision and scar that is virtually undetectable, plus less trauma to tissue, according to Ethicon.
The device can be used to perform multiple surgical jobs during laparoscopic operations, such as grasping and dissecting.
The FDA said the device was the fourth this year to be approved through its de novo process, which is a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device.
[Photo from flickr user Army Medicine]
