The randomised controlled trials have now been published and set the gold standard. These trials provide the best data for bodies such as the UK National Institute for Health and Clinical Excellence (NICE). The UK EVAR trials have reported at 10 years and these results will inevitably be used in the next cost-effectiveness assessment by NICE. Assumptions on more recent device improvement will be made. With an array of new EVAR devices on the horizon, patients can hope for much better results than historically seen in the meticulously followed data of the trials. Many more patients will be suitable for EVAR with the advances.
Vascular specialists have been presented with different devices since Juan Parodi and colleagues performed the first endovascular aneurysm repair in Argentina on 7 September 1990. Two decades after that landmark operation, the technique has evolved immensely and new devices are now expanding the number of patients who can be treated with EVAR.
Medtronic’s Endurant was the first device of this new generation to be introduced in Europe. Endurant received the CE mark in July 2008 and since then, more than 10,000 devices have been implanted worldwide. Currently, Endurant is the most used abdominal aortic aneurysm stent graft in Europe, witharound 40% of the market according to the European Vascular and Endovascular Monitor (EVEM). In the final results of the European Endurant Trial, presented by Hence Verhagen, at the CX Symposium, outcomes up to 12 months for safety and effectiveness with the device were very positive with 100% deliverability, zero ruptures, no type I/III endoleak and a high technical success rate. Endurant is able to treat, Verhagen said, more patients with challenging anatomies.
“This endograft seems to combine a few unique features: Ability to be deployed with high precision, ease of use, conformability to the original anatomy, and very low profile,” Verhagen said. Real-world data is being collected through the ENGAGE registry which will include 1,200 patients with five years of follow-up.
Zenith Low Profile
The launch of Cook Medical’s new Zenith Low Profile stent graft in July 2010 opened this year’s season of novel devices.
With its low profile delivery system, the new Zenith is expected to provide physicians with the very best tools to treat aortic disease in the most challenging of settings, according to Cook. The device will initially be available at 20 European centres where Cook will conduct a registry to capture patient outcome data for later publication. A full rollout of the device to all European physicians is planned for the third quarter of 2010.
Timothy Resch, consultant vascular surgeon, Skåne University Hospital in Sweden, involved in the initial trials of the Zenith Low Profile, said: “While EVAR has gained huge popularity in recent times for the treatment of abdominal aortic aneurysms, the technique cannot be used for certain subsets of patients. The alternative is traumatic open surgery, which can be a major burden or indeed completely unsuitable for frail or elderly patients due to long recovery times. Technologies that aim to address this niche help us provide endovascular treatment options for more and more patients.”
With a low-profile delivery system diameter of 16F and simplified deployment for precise delivery, the Zenith Low Profile represents a breakthrough for surgeons treating patients with difficult or tortuous access who might otherwise have been ineligible for EVAR. This patient group includes many women and smaller-bodied adults whose more narrow and angulated arteries can impede the accurate positioning of an endovascular graft using currently available larger-diameter delivery systems.
The Zenith Low Profile is significantly smaller than most commonly used EVAR delivery systems measuring 20–24F.
The next launch expected this year is the new Gore Excluder endoprosthesis featuring the C3 delivery system. The device has a recapturable andrepositionable proximal deployment system able to provide a more accurate proximal deployment sequence. “C3 is a big step forward,” said Eric Verhoeven, Klinikum Nuremberg, Germany. The first experience with the device will be presented by Richard McWilliams, Liverpool, UK, at the CIRSE congress in Valencia in October.
This year, Cordis has begun the INNOVATION trial, which will assess the safety and performance of the new Incraft stent graft. The initial procedures using Incraft were performed by Dierk Scheinert, Park-Krankenhaus Hospital in Leipzig, Germany, who is the principal investigator of the trial. “We have been excluding a significant portion of our abdominal aortic aneurysm patients, especially women, from EVAR because current stent grafts have large and bulky delivery systems, making device introduction impossible for small or diseased access vessels. The ultra-low profile delivery system of Incraft will make EVAR a possible treatment alternative for a wider range of patients,” Scheinert said. Currently available EVAR devices have a system profile ranging from 18 to 24F. Incraft’s delivery system profile is 13F.
Endologix has recently announced that the company has continued to advance its lower profile system, which will be called AFX for anatomical fixation. The company expects to submit a pre-market approval supplement for AFX before the end of this year with a potential US approval in 2011. Endologix expects to receive CE mark for AFX and begin treating patients outside the US with the new device in 2011 as well.
Another device being tested in Europe is the Ovation stent graft, from Trivascular. Its low-profile system expands the patient population suitable for EVAR by addressing a wider range of diseased anatomy. The first clinical study implants of the low-profile system were performed in Germany by Thomas Nolte, chief of Vascular Surgery at Herz- und Gefäßzentrums Bad Bevensen, and Horst Sievert, director of the CardioVascular Center Frankfurt.
“Ovation performed exceptionally well,” said Nolte, principal investigator for the European study. “The clinical benefits of the reduced profile and unique sealing technology were evident immediately. I believe this offering will expand the pool of patients to whom I can offer an endovascular solution.”
The European clinical study will evaluate the safety and performance of the Ovation system. In the USA, the Ovation stent graft is an investigational device and currently not approved for sale.
“I was very pleased with the performance of the Ovation stent graft,” said Sievert. “The system was easy to use and addresses many of the limitations of current generation devices, especially in cases of difficult anatomy and iliac access.”
Bob Mitchell, Palo Alto, California, USA, spoke at the Innovation Showcase, at the CX Symposium 2010, about Nellix, another device that is yet to be launched. Mitchell highlighted that there was an unmet clinical need in EVAR devices with respect to the high instances of endoleak, device migration, durability of the procedure, difficult anatomies, and secondary procedures. He said that Nellix has been specifically designed to overcome the limitations of current EVAR devices. It is a sac-anchoring device, which is not dependent on proximal or distal fixation. Due to its complete and continuous tissue contact, there is no possibility of developing an endoleak. It is a device with unmatched stability, suitable in adverse “no-neck” anatomy and can treat complex iliac aneurysms.
In the USA, Lombard has advanced in its aim of securing approval for the Aorfix stent graft. In August, the FDA approved the third of six modules of the company’s pre-market approval filing plan. The third module includes information pertaining to sterilisation, packaging and shelf-life of Aorfix, and is one of five modules covering FDA-required preclinical testing for the device. Modules one and two, which included information on biological testing and non-clinical laboratory studies have already received FDA approval. The company expects to file the last two non-clinical modules during 2010, with the filing of the final clinical module of the pre-market approval planned for the first half of 2011.