Lombard Medical Technologies (NSDQ:EVAR) today touted the 1st commercial use of its IntelliFlex low profile delivery system designed to implant the Aorfix endovascular stent graft in a procedure to treat an abdominal aortic aneurysm.
The procedure was performed by Dr. Nilo Mosquera at Spain’s Complexo Hospitalario Universitario de Ourense on the 28th of June, the Irvine, Calif.-based company said.
“My surgical team and I were very pleased with the performance of IntelliFlex LP. The device’s lower catheter profile was able to successfully navigate this particular patient’s calcified access vessels, something that in our experience might have not been possible with the previous generation’s delivery profile. The enhanced control of the new Y-mechanism is a significant improvement in stent delivery technology and provides greater control and precision when deploying the proximal end of the devices, allowing for a very precise graft placement. The integrated exchange sheath is also beneficial in reducing potential vessel trauma and facilitates the less invasive percutaneous approach,” Dr. Mosquera said in an SEC filing.
The Intelliflex system, in addition to allowing for the delivery of the Aorfix endovascular stent, includes an integrated exchange sheath designed for the delivery of ancillary devices during the procedure, the company said. The design removes the need for catheter exchanges, which Lombard said saves procedure time, blood loss and possible vessel trauma.
“The user and procedure advantages of the IntelliFlex LP together with the outstanding long-term Aorfix clinical data will provide physicians with an even more compelling reason to use this technology to treat an even greater range of patient anatomies. We believe our portfolio approach with our patient centered combination of Aorfix with IntelliFlex LP to treat complex anatomy and our new Altura stent graft which delivers multiple advantages for the treatment of patients with more routine AAA anatomy, will provide physicians with greater treatment options. We believe this product combination will be a significant driver of revenue growth in 2016 and beyond. We look forward to our European commercial launch of IntelliFlex in July,” CEO Simon Hubbert said in a prepared statement.
Lombard said it plans to begin shipment in July to its direct markets in the U.K. and Germany, with a full commercial launch in other European markets later this year.
In late July, Lombard said it won CE Mark approval in the European Union for its IntelliFlex low profile delivery system for its Aorfix endovascular stent graft.
The system is designed for the delivery of the company’s abdominal aortic aneurysm Aorfix endovascular stent graft, and includes an integrated exchange sheath designed for the delivery of ancillary devices during the procedure, the company said. The design removes the need for catheter exchanges, which Lombard said saves procedure time, blood loss and possible vessel trauma.