- B. Braun Interventional Systems said Thursday it received FDA’s breakthrough device designation for its SeQuent Please ReX paclitaxel-coated balloon catheter for the treatment of in-stent restenosis, in which the artery re-narrows after a stent implant, in patients with coronary artery disease (CAD).
- FDA’s breakthrough device pathway expedites the clinical trial and regulatory review process for novel technologies. There are currently no coronary drug-coated balloon catheters approved in the United States, according to B. Braun.
- The company plans an investigational device exemption clinical trial for the device, a B. Braun spokesperson told MedTech Dive.
B. Braun’s device development comes at a time of heightened scrutiny on paclitaxel-coated balloons and paclitaxel-coated stents for the treatment of peripheral artery disease in the legs. However, B. Braun’s paclitaxel-coated balloon catheter is intended for use in coronary artery disease patients, not PAD.
In June, FDA's Circulatory System Devices Panel Advisory Committee agreed with an agency staff assessment that a mortality signal is associated with paclitaxel-coated balloons and paclitaxel-eluting stents in PAD. Manufacturers BD, Medtronic, Philips and Cook Medical argued there isn’t a mortality signal present. The panel determined the devices should remain on the market but with new labeling to warn of the safety signal.
The FDA panel’s conclusions follow a May statement from Europe-based doctors' group PCR on the use of paclitaxel drug-coated balloons in peripheral interventions that called for further study. The statement noted that no long-term safety signal has ever been shown in such cases.
In-stent restenosis remains a challenge in interventional cardiology. While drug-eluting stents are used to address the issue, in-stent restenosis continues to affect a subset of patients. About 5% of patients who receive a drug-eluting stent and more than 30% of patients who undergo bare metal stent implantation develop in-stent restenosis, according to one study.
B. Braun told MedTech Dive that availability of its investigational drug-coated balloon for coronary in-stent restenosis would allow patients the opportunity to avoid receiving another permanent stent implant and could limit the associated post-procedure medication regimen.
The balloon catheter used with the SeQuent Please Rex is the company's SeQuent Neo catheter — an uncoated version — that received FDA 510(k) clearance in 2017, B. Braun said. Two earlier versions of SeQuent Please drug-coated coronary balloon catheters have been marketed outside the United States since 2009.
All earlier versions of SeQuent Please drug-coated balloon catheters have demonstrated equivalent safety and effectiveness in the treatment of coronary in-stent restenosis, the company said. Twelve studies involving a total of 1,715 patients have been published that evaluated SeQuent Please catheters for de novo disease and in-stent restenosis, including the DARE trial that found SeQuent non-inferior to Abbott's Xience everolimus-eluting stent.