Attendees at the CX Innovation Showcase learnt about the latest branched devices for endovascular aneurysm repair yesterday. New technologies for the vascular and endovascular treatment of lower limb, venous and carotid disease and arteriovenous access were also discussed. Stephen Greenhalgh (London, UK) and Andrew Holden (Auckland, New Zealand) were the chairmen of the session.
Greenhalgh told CX Daily News that the objective of this year’s session was “to get an idea of the pipeline of the major companies to tackle branched endovascular aneurysm repair.”
Among the branched devices featured at the CX Innovation Showcase, Michel Makaroun, Pittsburg, USA, presented on the investigational TAG thoracic branched endograft from Gore. He said that the design of this off-the-shelf device started “nearly a decade ago”.
The device has been built upon existing aortic and peripheral platforms and can be adapted to many anatomies. It is easy to use, requiring only femoral access and minimal manipulations, and is safe with minimal risk of branch coverage, he noted. The device has an aortic component which incorporates an internal portal allowing seal and fixation of the side branch component. The device diameters are between 21 and 53mm and the aortic treatment ranges between 16 and 48mm. “We have very early clinical experience with the device and it has been positive so far,” he concluded.
Zenith T-Branch and P-Branch endovascular grafts
Timothy Resch, Malmo, Sweden, spoke about Cook Medical’s Zenith T Branch and P Branch endovascular grafts, which are off-the-shelf systems for complex aortic repair. These devices, Resch noted, are aimed to “eliminate complex planning as well as manufacturing delays in the treatment of aortic aneurysms”.
The Zenith T Branch, designed to treat thoracoabdominal aortic aneurysms, has been CE-marked since 2012. Resch explained that the system consists of two main components that are compatible with the existing Zenith Thoracic Endovascular Aortic Repair (TEVAR) and iliac limbs components for proximal and distal extension depending on the aneurysm extent. The first component is a standard multi-branched device aimed at preserving flow into the main visceral side branches of the aorta. The second component is a “unibody” bifurcated device that comes in five different total lengths to match the individual anatomy. “Planning is simplified by using a predesigned planning sheet where the extent of the aneurysm as well as position of the target vessel ostia are marked,” he noted.
Resch highlighted that clinical and anatomical studies have determined that the applicability of the device in the treatment of thoracoabdominal aortic aneurysm ranges from 70 to 80% of the cases and multicentre studies are ongoing to evaluate further the applicability and efficacy of the device.
Resch went on to present the Zenith P Branch endovascular graft. He said that this device is designed to treat juxtarenal and suprarenal aneurysms as well as short neck infrarenal aneurysms which are not suitable for standard infrarenal EVAR. “As with the T Branch system, the P branch has two main components and is compatible distally with standard Zenith iliac limb extensions,” he said. In contrast to the T Branch, the P Branch it consists of a main body including two fenestrations for the renal artery and one for the superior mesenteric artery as well as a scallop fenestration for the coeliac trunk. Planning is done in a standardised fashion using a planning sheet and a template outlining the device.
Resch told delegates that anatomical studies in patients with juxtarenal abdominal aortic aneurysm have estimated the applicability of the P Branch to 50–70% but clinical data are still lacking. The device is not commercially available and international, multicentre feasibility studies are ongoing.
Relay branched endograft
In a subsequent presentation, Toru Kuratani, Osaka, Japan, talked about early and midterm results with the Relay branched endograft from Bolton Medical. He told delegates that he has been using the device, which is comprised of a flexible main body and two internal tunnels inside the main body, since 2013.
Early results in 12 patients treated with the Relay endograft have shown positive outcomes with 100% procedural success rate, no endoleaks, stroke or major complications, Kuratani noted. At six months and 12 months, there was a 100% survival rate and 100% freedom from aortic events. He said that endovascular repair with this device “may become a wonderful option for high risk patients.”
Martin Funovics (Vienna, Austria) presented a new branched endograft from Jotec. He told delegates: “If off-the-shelf technology fails, this is where the new technology from Jotec might jump in.” The device is adaptable to variable design choices and the branches are flexible with easy cannulation, he noted. He reported that the initial results were also promising.
The Nellix sealing system was featured at the Innovation showcase with presentations from Andrew Holden, Auckland, New Zealand, and Bob Mitchell, Hertogenbosch, The Netherlands. Mitchell told delegates that Nellix is a “game changer” in the treatment of abdominal aortic aneurysms. He said: “Nellix is not simply a next generation EVAR device, but it is rather a completely different approach to abdominal aortic aneurysm therapy. Nellix stands alone as the one and only alternative to EVAR.” This is a breakthrough concept designed to dramatically reduce known EVAR complications such as endoleaks, migration and reinterventions, he added.
As a highlight in the latest carotid innovations, Sumaira Macdonald, Sunnyvale, USA, spoke on the Michi system (Silk Road Medical), a cervical access approach that is used to reduce the risk of microemboli in carotid stenting. Macdonald told the audience that early results with the device “are encouraging” and “may represent a paradigm shift in the management of carotid artery disease.”
In the lower limb session, Michael Orlowski presented data for the Legflow Paclitaxel-Eluting Peripheral Balloon Dilatation catheter from Cardionovum.
David Deaton, Washington, USA, spoke on the Rox device for endovascular arteriovenous fistula; and Steve Elias, Englewood, USA, presented data on Clarivein, an endovenous ablation system used in the treatment of varicose veins.
Concluding the session, Greenhalgh told CX Daily News that there is a clear call from the audience for more evidence and more data from the technologies showcased. However, he added: “It is wonderful to see the rich pipeline of new devices that are coming.”
Physicians share new product ideas at “Speed Dating” event
For the first time at the Charing Cross Symposium, physicians shared their product ideas with experienced physician inventors, engineers and marketing experts in an event called “Speed Dating”. The event was held at the Innovation Showcase yesterday. Physician inventor David King (London, UK) won the “Dragons’ Den CX Innovation Showcase prize”.
Jean Bismuth, Elika Kashef and Stephen Greenhalgh, chairs of the session, designed the event to provide a platform for physicians who are seeking advice from experts on how to put their business and product ideas onto market.
Bismuth explained the rationale for the event: “Many young physicians and even senior physicians—as they gain experience through the years—have a desire to design their own medical tools and they start thinking and developing the idea. Unfortunately, sometimes they cannot get their innovations onto the market because they do not have the access to the experts to take the idea to the next level. With this “speed dating” event, we want to collaborate to bridge that gap.”
At the event, physicians had the opportunity to speak first to a group of physicians who have experience developing devices, then to engineers and finally to marketing experts.
“Protect your idea” was the main advice that experts gave to the participants.
After the “Speed Dating” event, the Dragons’ Den CX Innovation session took place and awarded David King with £1,000 for his innovative idea. King designed a Doppler device called “Blue Dop” that works via a tablet device. He said that it uses a special algorithm that can measure blood pressure without the need to use a cuff or needles. He noted that the device is unique in the market and can be used in renal dialysis, arterial disease and sports medicine.