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Briefs

February 1, 2019

J&J, DePuy Settle State Hip Implant Cases for $120 Million

Johnson and Johnson and its DePuy subsidiary agreed to pay $120 million to settle multistate lawsuits alleging false claims and unfair marketing of their metal-on-metal hip implant devices.

The 46 states that accused DePuy of making false claims about the longevity of the ASR XL and Pinnacle Ultamet metal-on-metal hip implant devices will share the settlement. Texas, for example, will receive $8.5 million.

Under the agreement, DePuy will reevaluate and revise its marketing and promotion strategies for the hip implants, including its use of scientific data to support advertising claims. The company said the settlement involves no admission of liability or misconduct.

Researchers Develop New Blood Flow Imaging Tool

A research team at Northwestern University has developed a 3-D imaging device that can track blood flow through capillaries.

The device can detect tiny changes in capillaries using spectral contrast optical coherence tomography angiography (SC-OCTA) — a 3D-imaging technique useful for early identification of diseases.

The technology doesn’t depend on injected dyes for contrast and requires no radiation. It can also image blood whether it’s stagnant or in motion, allowing it to image the heart and other moving organs.

“There has been a progressive push to image smaller and smaller blood vessels and provide more comprehensive, functional information,” says Vadim Backman, the team’s leader. “Now we can see even the smallest capillaries and measure blood flow, oxygenation and metabolic rate.”

The device currently cannot image deeper than one millimeter, but that can be circumvented by attaching the tool to an endoscopic probe, which enables it to perform close-up imaging of a patient’s organs.

French Regulators Greenlight Ultrasound Trial for Glioblastoma

French regulators approved a Phase I-2 clinical trial of an ultrasound device to treat recurrent glioblastoma.

French-based CarThera is hopeful that its implantable SonoCloud-9 will help open up the blood-brain barrier in patients with recurrent glioblastoma who are eligible for carboplatin chemotherapy.

The device issues low-intensity pulsed ultrasound and it’s already proved safe and effective for patients in the short-term. The company has just won French approval for an open-label dose escalation study that will enroll 20 patients over the next year.

CarThera officials are hoping for FDA approval to extend the trials to the U.S., in the MD Anderson Cancer Center in Houston and Northwestern Memorial Hospital in Chicago.