Last month, Ethicon Endo-Surgery launched the newest iteration of its Harmonic Ace+ shears, the Harmonic Ace+7 with Advanced Hemostasis. The company billed the product as the “first purely ultrasonic device with a 7-mm sealing indication,” and a press release included a number of favorable comparisons with Covidien’s LigaSure vessel-sealing instruments.
But now Covidien is alleging the Harmonic Ace+7 infringes on three of its patents. In a lawsuit filed June 24, 2014, in the U.S. District Court for the District of Connecticut, the company asked the court to stop Ethicon from making and selling the Harmonic Ace+7 and to grant Covidien damages for patent infringement.
This isn’t the first time the two companies have come to blows over Ethicon’s Harmonic devices and Covidien’s 6,063,050; 6,468,286; and 6,682,544 patents. In a lawsuit filed in 2010 in the same court, Covidien contended that “many of Ethicon’s Harmonic devices” infringed on the very same patents, and in 2013 the court awarded Covidien $176.5 million in damages, though the ruling is currently under appeal.
Whether Ethicon did indeed steal Covidien’s technology is a question for the courts. But Ethicon did have its competitor in mind during development of the Harmonic Ace+7.
In a phone interview, Ethicon vice president of R&D Rob Laird told me the company recognized that it needed to update its ultrasonic product to better compete with Covidien’s advanced bipolar vessel sealing products. Ethicon’s Harmonic ultrasonic technology, he said, was better for precise dissection, but it didn’t do as good of a job at sealing.
“It didn’t match up to what you could do with an advanced bipolar device,” he said.
As a result, Laird said some surgeons would either have to make a tradeoff or—at least in the old days, before costs became a primary consideration—use two devices.
When Ethicon went back to the drawing board to develop the Harmonic Ace+7, Laird said the team’s goal was to close the loop to create a product that offered both precision dissecting and great sealing. “If you had to boil it down, it’s about no tradeoffs,” he said.
In the end, Ethicon says the Harmonic Ace+7 fits the bill. In a press release, the company says the device, which won FDA 510(k) clearance in October 2013, provides greater 5–7 mm vessel sealing reliability than Covidien’s LigaSure devices, 140% higher median burst pressure than the LigaSure 5-mm Blunt Tip, and 112% higher median burst pressure than the LigaSure Advance.
MD+DI reached out to an Ethicon spokesperson for comment on the lawsuit filed by Covidien and received the following:
Ethicon firmly stands behind our products and intellectual property which allow us to advance patient care by bringing innovative medical devices to the market. We can and will continue to make our HARMONIC® devices available to our patients and customers; this includes game-changing devices like HARMONIC ACE+7.
Per our company policy, we do not comment on any ongoing litigation outside of saying that we feel that we have strong legal defenses to both the lawsuit and to oppose the injunction.
—Jamie Hartford, managing editor, MD+DI
[image courtesy of ETHICON ENDO-SURGERY]