Cordis Corp. said today that 4-year data from a trial of its Incraft abdominal aortic aneurysm stent graft system showed it “performed well” in patients suffering from AAAs 4 years after treatment. Data from the study was presented at the VEITHsymposium in New York City this week.
The multi-center, open-label prospective Innovation trial reported a 97% freedom from endoleaks and no stent graft migrations after 4-years.
“With the 4-year study results demonstrating continued performance with the Incraft System in Europe, Cordis’ device is clinically established in a class of next-generation AAA devices. In clinical practice, the Incraft System is easy to use and has one of the lowest profiles of any endograft on the market. I strongly believe that the Incraft System will continue to be a valuable option for physicians who remain eager for new technologies to enhance their ability to effectively treat patients with AAA,” study investigator Dr. Giovanni Torsello of Germany’s St. Franziskus Hospital said in a press release.
The Incraft is designed for the endovascular treatment of patients with infarenal AAA, featuring a 14F outer diameter including the integrated sheath, which the company says is equivalent to a 12F catheter sheath introducer profile. Cordis says that is smaller than the average EVAR stent graft which range between 16F and 22F.
“We spent nearly a decade working with a talented team of interdisciplinary cardiovascular physicians to perfect the design of the Incraft System and ensure the device would enable greater access to a life-saving therapy for AAA patients. Today, the Incraft System is being used by doctors in regions around the world and the safety, durability and performance of the device is supported by a growing body of evidence as seen with the 4-year Innovation study data,” prez David Wilson said in prepared remarks.
The Incraft system won approval for use in Europe and Canada last year, and is also cleared in Mexico, Columbia and Brazil. The device won FDA investigational device excemption in the U.S., and is cleared for investigation in Japan.
Last month, Cardinal Health (NYSE:CAH) closed its $1.94 billion buy of Johnson & Johnson‘s (NYSE:JNJ)’s Cordis stent-making arm.
The New Brunswick, N.J.-based healthcare giant announced the deal to pick up the cardiology and endovascular business from J&J in March
The massive acquisition, which is worth some $1.59 billion net of tax benefits, offers annual synergies in excess of $100 million by the end of fiscal 2018, Cardinal Health said when it announced the deal.
The post Cordis touts 4-year data on Incraft AAA stent graft appeared first on MassDevice.
from MassDevice http://ift.tt/1kL9Zbr
Cap comentari:
Publica un comentari a l'entrada