Yesterday, the CX Innovation Showcase reviewed technological developments happening in all areas of the Charing Cross (CX) symposium: acute stroke, aortic, peripheral, venous, vascular access, and wound care. Additionally, a new “Dragons’ Den” winner was crowned.
In the first talk of the session, Lindsay Machan (Vancouver, Canada) talked about the lessons he had learnt from being a founder of Angiotech—developer of the paclitaxel-coated stent. He said one of the hardest lessons to learn was to recognise that his skillsets were “not running businesses”, adding “it is not even my interest”. Machan also had to accept that “large companies do not care about your timetable” and, according to him, made decisions “based on a negative rather than a positive”. “The deal Boston Scientific and Cook Medical made with Angiotech only happened after a cash offer from a competitor. That was almost two years after doing the dance with these companies,” Machan observed. He added: “Be very clear about expectations from both sides. It is OK to talk about specific expectations and rewards.”
Machan also spoke about the use of artificial intelligence as “clinical decision support”, giving the example of “smart speakers” that can be used in the angiography room or cath lab to determine the optimal size of stent or the cost of a particular device. Ultimately, he noted that “artificial intelligence will not replace physicians; physicians who use artificial intelligence will replace those who do not”. Tom Carrell (Barrington, UK), the CEO of Cydar Medical (which has an artificial intelligence system), who gave a presentation after Machan, also advocated that the role of artificial intelligence was to support physicians rather than to replace them. “We think it is cloud, data, and artificial intelligence—the combination of the three; the trinity—that leads to better patient outcomes,” Carrell commented.
Peripheral innovation, with a focus on paclitaxel
As well as artificial intelligence, there was also a focus on peripheral innovation—looking at new technologies and alternative to paclitaxel. Peter Gaines (Sheffield, UK) noted that “sirolimus has the potential to improve patient outcomes” while Edward Choke (Singapore) discussed the benefits of the New Xtreme Touch sirolimus-coated balloon and Andrew Holden (Auckland, New Zealand) reviewed the use of the Temporary drug coated spur system to address the challenges of drug-coated technology. Holden observed the system was a novel technology that provided localised drug delivery, had multiple applications, and “left nothing behind”.
Moving the session along, York Hsiang (Vancouver, Canada) said to the CX audience: “A lot of the discussion as to how we can improve stents has focused on the coatings of stents. We decided to use a completely different approach by using microelectronics.” He then introduced delegates to a new, prototype smart stent to monitor blood flow and detect restenosis. He commented: “The trouble with in-stent restenosis is that one never knows when you are having a problem, until one has a problem”, he said, showing a slide of a patient with in-stent restenosis having a myocardial infarction. When originally designing the device, he had postulated that if a physician could gain information about what was happening in the stent itself, then they could determine if there were any haemodynamic changes, such as pressure difference, and then use this information to detect stent stenosis. Hsiang and his team developed a prototype smart wireless stent with an integrated micropressure sensor, both of which were made of medical-grade stainless steel and then microwelded together. In an animal model, the custom device demonstrated real-time wireless tracking of local blood pressure over 100mmHg change.
Another “new, innovative” device was presented by Elias Noory (Bad Krozingen, Germany): the CaveoVasc protection system. Reporting on the results of the first-in-human trial of this device, Noory said that there was no treatment failure, no major bleeding at the puncture site, and no relevant haematoma at the puncture site. Describing the effects of the “double balloon technique” he used, Noory said the method reduced the bleeding complications during catheter-directed thrombolysis.
The CX Innovation Showcase also highlighted several aortic innovators, including: Mario Lachat (Hinteregg, Switzerland), who spoke about an off-the-shelf endograft for arch aneurysms; Bao Bui (Sherbrooke, Canada), who talked the audience through an expandable modular branched graft; and Jan Heyligers (Tilburg, The Netherlands), who detailed his experience of in-house 3D printing for complex aortic endovascular denervation.
Furthermore, Matt Thompson (Irvine, USA) spoke about the endovascular aneurysm sealing (EVAS) device (Nellix) and whether “it was a failure or a phoenix”. In January, the CE mark for Nellix was revoked and Endologix issued a voluntary recall of the remaining stock of the device on the market. Therefore, in his talk, Thompson said that the current options were to “give up”, “continue”, or to “bring out a new device”. If the option is to continue in some way, Thompson commented, you have “go slowly, go carefully, and not leap ahead”.
Ramifications of the EU medical devices regulations
A special lunchtime session of the Innovation Showcase focused on the new EU medical devices regulations (MDR). Peter Gaines (Sheffield, UK) looked at the payer, provider, and patient perspective, Aine Smalley (Santa Rosa, USA) gave the large company perspective, Gido Karges (Wangs, Switzerland) gave the small company perspective, and Jeffrey Jump (Mont-sur-Rolle, Switzerland) reviewed the innovation perspective. Although the speakers came from different positions, they all expressed concerns about the new regulations and the impact they would have on the availability of devices, both on the market and for patients. Jump commented that “innovation will continue” after the regulations came into force but noted: “We know from what is published that innovation in Europe will be more expensive, take longer, and offer less choice to physicians and patients.”
Returning to the CX Innovation Showcase in 2019, eleven entrepreneurs entered the “Dragon’s Den” to present their ideas to an expert panel. These panellists were: Andrew Holden (Auckland, New Zealand), Frans Moll (Utrecht, The Netherlands), Bob Mitchell (Irvine, USA), Peter Philips (Didcot, UK), Chas Taylor (Horsham, UK), Jeffrey Jump (Mont-sur-Rolle, Switzerland), and Alan Edwards (Ruthin, UK).
Dragons voted for Petra Apell (Gothenburg, Sweden) to win the £1,000 prize for her and her colleague’s work on the HeadPeace radiation protection textile. Her colleague is Fredrik Gellerstedt (Goteborg, Sweden)
Other innovators and their work were:
- Hans Henkes (Stuttgart, Germany)—Phenox hydrophilic coating for reduced thrombogenicity of stents.
- Sean Morris (Missouri City, USA) —Nanoscale medical devices: a new frontier in the treatment of critical limb ischaemia.
- Colette Cook (Ellesmere Port, UK) —Community portable infrared thermography: improving outcomes in patients with diabetic foot disease.
- Cees Wittens (Maastricht, The Netherlands) —Second-generation venous stent.
- John Martin (Annapolis, USA) —Butterfly iQ pocket-sized ultrasound.
- Paolo Spada (Buccinasco, Italy) —EVARPlanning’s platform.
- Cecile Feracci (France)—4EVAR adjunctive technology.
- Dai Yamanouchi (Madison, USA)—Single nanometer oxygen nanobubble.
- Claude Mialhe (Monaco) —New cap for endovascular.