Applied Medical Archives - Medical Design Sourcing

FTC critiques Medtronic’s legal reasoning in antitrust case

The U.S. Federal Trade Commission wants to have a say in Applied Medical Resources’ antitrust lawsuit against Medtronic.

Rancho Santa Margarita, California–based Applied Medical filed the lawsuit in February in U.S. District Court in Central California.

The lawsuit accuses the medtech giant of using its size to shut down competition in the U.S. market for advanced bipolar devices used to cut tissue and seal blood vessels. Medtronic responded with a motion to dismiss.

This week, the FTC sought permission from the court to file an amicus brief that would “correct some of Medtronic’s erroneous assertions and mistaken legal points” made in its argument for dismissal.

Medtronic’s legal arguments run against U.S. Supreme Court precedent that anticompetitiveness should not be judged according to a business arrangement’s formal terms but on its its “practical effects,” the FTC said in the brief it wants to submit.

What Applied …

Medtronic faces antitrust lawsuit over surgical devices

The Voyant advanced bipolar system [Image courtesy of Applied Medical Resources]Applied Medical Resources is accusing Medtronic (NYSE:MDT) of using its size to shut down competition in the U.S. market for advanced bipolar devices used to cut tissue and seal blood vessels.

Rancho Santa Margarita, California–based Applied Medical filed an antitrust complaint yesterday in Central California’s U.S. District Court.

“We are proud to be a leader in this competitive and growing space,” a Medtronic spokesperson said in a statement shared with MassDevice. “The claims are baseless and Medtronic will defend against the lawsuit filed by Applied Medical.”

In its lawsuit, Applied Medical said Medtronic has a dominant 78% share of the advanced bipolar device market with its Ligasure device — and it has dominance when it comes to a host of other surgical devices.

The privately held company accused the publicly traded medtech giant of usi…

The worst catheter-based device recalls of 2020

Top: Teleflex Langston Dual Lumen catheter; Bottom: BSX Imager II, Endologix Ovation iX, Teleflex AC3 Optimus Intra-Aortic balloon pump

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA.

FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019.

The list of the most serious catheter-based device recalls in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.

Here are the nine most serious catheter-based device recalls of 2020.

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The worst catheter-based device recalls of 2020

Top: Teleflex Langston Dual Lumen catheter; Bottom: BSX Imager II, Endologix Ovation iX, Teleflex AC3 Optimus Intra-Aortic balloon pump

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA.

FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019.

The list of the most serious catheter-based device recalls in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.

Here are the nine most serious catheter-based device recalls of 2020.

Next >>

FDA labels Applied Medical catheter recall as Class I

The FDA announced yesterday that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall.

The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the U.S., having been manufactured between July 23, 2015, and Nov. 8, 2018, and distributed between Aug. 25, 2015, and March 1, 2019. The company initiated the recall on Oct. 24, 2019, according to an FDA release.

Get the full story at our sister site, MassDevice.