Long-term positive outcomes of Getinge’s Advanta V12 balloon expandable covered stent shows distinction in new systematic literature review

The review, published in the Journal of Vascular Surgery, was headed by Bibombe Patrice Mwipatayi, MD from the Perth Institute of Vascular Research, University of Western Australia. It included 15 published articles reviewing 14 clinical studies of different covered balloon-expandable (CBE) stents for aorto-iliac occlusive disease (AIOD). Eight of the studies covered prospective clinical trials and six were retrospective real-world studies.

“Each covered stent has a different design and technology, which means that it needs to be proven efficient and safe in its own trial,” said Dr. Mwipatayi.

The number of patients in reviewed Advanta V12/iCast studies totaled 611, compared to only 12 to 164 for the other reviewed devices. The duration of follow-up was longer for Advanta V12; between 8 and 60 months, compared with up to 12 months for the other stents.

Dr. Mwipatayi commented, “According to our analysis, long-term data is only available for a single device, the Advanta V12, with results favorable through five years.”

The technical success, patency, and freedom from target lesion revascularization (TLR) at 12 months were similar among the reviewed devices. Beyond the first year, however, Advanta V12 is the only device with data out to five years, with primary patency of 74.7%.

As Advanta V12/iCast publications included real-world studies, these patients had  more severe disease as compared  with patients who received  other stents. Disease severity was defined as the percentage of total occlusions and lesion length. The Advanta V12/iCast included a greater number of TASC (TransAtlantic Inter-Society Consensus) C/D lesions than LifeStream or BeGraft studies. The Getinge device was also the only device to currently have long-term data for primary patency and freedom from TLR.

“Real-world data is essential to demonstrate longevity of performance. In the past, there have been devices that looked positive in the first year, but after two or three years the patency dropped off dramatically.” said Jean-Paul de Vries, MD from the University Medical Center Groningen, the Netherlands, a co-author of the review.

Advanta V12/iCast has a history of use in over 500,000 patients, with its ease of use and reliability, discussed in some of over 550 clinical publications.

“The results of this review show a favorable outcome for our well-proven Advanta V12 balloon expandable covered stent compared to newer devices,” says Jens Viebke, President Acute Care Therapies at Getinge.  “Getinge’s Advanta V12 has been trusted by physicians for more than 15 years with solid clinical evidence.” Our stent continues to prove itself every day when it comes to helping patients with this severe condition.”

Aorto-iliac occlusive disease
Aorto-iliac occlusive disease occurs when atherosclerosis narrows and blocks the peripheral arteries which supply blood to the legs and feet. As the world population ages and rates of diabetes and obesity rise, it is estimated that more and more persons will be affected by aorto-iliac occlusive disease, which puts them at risk for serious complications such as amputation.

The authors
The authors of the review, which has been published in the Journal of Vascular Surgery, are B. Patrice Mwipatayi, MD, Kenneth Ouriel, MD, Tahmina Anwari, MBChB, Jackie Wong, BSc, Eric Ducasse, MD, Jean M. Panneton, MD, Jean-Paul P. M. de Vries, MD and Rajesh Dave, MD.

This information is intended for an international audience outside of the US.

The Advanta V12 is indicated for restoring and improving the patency of the iliac and renal arteries. Renal approval includes 5 mm, 6 mm and 7 mm diameter Advanta V12 sizes. Advanta V12 has Canadian Health Ministry license for restoring the patency of iliac lesions.

The iCast Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.