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August 1, 2019

FDA Breakthrough Device Designation Granted for B. Braun's SeQuent Please ReX DCB for In-Stent Restenosis

August 1, 2019—B. Braun Interventional Systems, Inc. announced that the FDA has granted Breakthrough Device designation for the company's SeQuent Please ReX drug-coated percutaneous transluminal coronary angiography balloon catheter for the treatment of coronary in-stent restenosis.

In the company’s press release, Jorge Saucedo, MD, commented, “We need to have a coronary drug-coated balloon in our toolbox to treat patients. This Breakthrough Device designation brings the technology a step closer for our use.” Dr. Saucedo is Chief of Cardiology at the Medical College of Wisconsin in Milwaukee, Wisconsin.

The goal of the Breakthrough Device program is to provide patients and health care providers with timely access to the medical devices that treat life-threatening or irreversibly debilitating diseases. By speeding up the development, assessment, and review of the SeQuent Please ReX and preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization, the designation will streamline the process and timeline for bringing this treatment option to appropriate patients in the United States, stated the company.

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August 1, 2019

FDA Approves IDE for PROACTIVE-HF Pivotal Trial of Endotronix's Cordella Pulmonary Artery Pressure Sensor System

July 30, 2019

Alvimedica Receives European Approval for 1-Month DAPT After Implantation of Cre8 and Cre8 Evo DES