Cook Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Zenith Thoraco+ Endovascular System (Thoraco+).
Thoraco+ is the company’s second product to receive the FDA breakthrough status this year, following its drug-eluting stent for below the knee (BTK), granted in February.
The US-based medical device company said that its endovascular system has been developed leveraging the capabilities of its Zenith platform.
Thoraco+ is a new-generation endovascular graft indicated for the treatment of patients with thoracoabdominal aortic aneurysms (Crawford classification I-IV).
It is an off-the-shelf device that includes four side branches for the celiac artery, superior mesenteric artery, left renal artery, and right renal artery.
The new Thoraco+ will be offered in wide a range of diameters and lengths, to address the diverse patient anatomies.
Cook Medical vascular division senior vice president Mark Breedlove said: “We are excited to receive an FDA Breakthrough Device Designation for the Thoaraco+.
“This will be a great addition to our portfolio of aortic products so we can offer treatments to a wider variety of patients.”
With the designation, the company can benefit from FDA priority review, and timely communication during the clinical trial and pre-market review phases.
Established in 1963, Cook Medical is engaged in inventing, manufacturing and delivering a portfolio of medical devices that prevent the need for open surgery.
Earlier this year, the company has signed a letter of intent with CooperCompanies to sell its entire reproductive health business within the MedSurg division for around $875m.
Cook Medical’s reproductive health business manufactures minimally invasive medical devices for the fertility, obstetrics and gynaecology markets.
CooperCompanies is a healthcare company focused on women’s health and fertility solutions, and provides products and services related to ART journey.
