The Israeli Innovations in Cardiologic Interventions (ICI) conference lived up to its reputation at the recent Tel Aviv conference. An event modeled on the annual TransCatheter Technology conference (TCT), ICI aims to offer TCT's rigor and pioneering elements to a smaller forum. "Our environment", explained Chaim Lotan, MD, Director of the Heart Institute, at Hadassah Medical Center (Jerusalem), "is highly innovative. It is essential for us as clinicians and entrepreneurs in this relatively young subspecialty of Interventional Cardiology, to strengthen the dialogue between stakeholders in this system." ICI stands out in the elegant way it integrates science, medicine and business to enable the participant to visualize the development of concepts to products. Theories - often proposed by experienced physicians - can be seen to have advanced from year to year, whether taking pre-clinical data towards a small trial, or in moving from an early proof of concept to a more validated clinical solution. While truly evidence-based, the IC medical community is conscious of the critical professional and financial importance of continuously innovating.
As in previous years, the conference's innovation-charm was embedded in its investment of the first day's Academy of Innovation program: a set of seminars for physicians/engineers who wanted to better comprehend the interdisciplinary needs of the successful medical entrepreneur. "The optimal way for medical startups to develop" explained Chaim Lotan, Co-Founder of the Conference, "is to bring to them leaders in the worlds of VC, patents, industry and engineering." These hand-picked speakers expanded upon the complexity involved in the development of a suitably novel, and cost-effective device for the cardiology industry, "and explained the importance of learning from others' previous mistakes" added Lotan.
Martin Leon, MD, Director, Center for Interventional Vascular Therapy, Columbia University Medical Center (New York) and both TCT Co-Founder, and ICI Co-Director, described the growth of the subspecialty in his ICI keynote. The IC discipline was started with the arrival of balloon angioplasty, he explained, advanced when the stent arrived on the scene, and then further expanded as the drug-eluting stent (DES) went into (then out-of, and then somewhat into-) favor. Less invasive "Structural Heart" technologies have now advanced: procedures such as Transcatheter Aortic Valve Repair or Replacement (TAVR) are now at the cusp of growth. They help to divert the IC's attention from lower numbers and/or margins of previous mainstay cathlab procedures in key profitable geographies.
As always, ICI this year enabled some interesting new companies to present their progress towards a meaningful impart in the cardio-space.
Literally adding a new dimension is Realview Imaging (Yokneam, Israel) which is has developed the world's first 3-D holographic display and interface system. The company uses previously acquired images to create what they define as an image intimacy concept that enables the user to interact with a 'hyper-realistic, dynamic 3-D holographic image floating in the air'. Earlier this quarter, the company announced the successful completion of an eight-person study together with Royal Philips (Amsterdam, the Netherlands) to assess the feasibility of using the RealView technology to guide minimally invasive structural heart procedures. Elchanan Bruckheimer, PhD MBBS is Medical Director of RealView, Director of the Cardiac Catheterization Laboratories at Schneider Children's Medical Center (Petach Tikva, Israel). He added, "The ability to reach into the image and apply markings on the soft tissue anatomy in the X-ray and 3-D ultrasound images would be extremely useful for guidance of these complex procedures." Aviad Kaufmann, the company CEO, explained some of the advantages of the system: "The user can, in real time, have 'unbounded interaction' with the image: the image can be rotated, move, zoomed-in on, marked and measured - all in true space" Kaufman told Medical Device Daily.
Another company with a potential to play a key role in IC growth is V-Wave (Or Akiva, Israel), which is developing a novel implantable medical device for treating Chronic Heart Failure (CHF) in patients suffering from excessively high left atrial pressures (LAP). The V-Wave System consists of a transcatheter-delivered implantable shunt, placed across the fossa ovalis, between the left and right atria. A successful pre-clinical chronic trial on a HF sheep model was performed at Ohio State University (Columbus, Ohio) in early 2013. V-Wave has now advanced towards its First-In-Human trial at the Québec Cardiology and Respirology University Institute (Chemin Sainte-Foy, Quebec, Canada). The company plans to complete the first five patients during January 2014, and then evaluate the efficacy of the procedure at two additional sites (Germany & Israel). V-Wave is funded by Edwards Lifesciences (Irvine, California), major Israeli's VCs and experienced entrepreneurs from the Israeli cardiovascular industry.
A number of companies in the cardiothoracic arena were also presenting at the conference –showing the breadth of scope of the conference's proceedings. One company that was innovating in the Vein Graft business was Vascular Graft Solutions (VGS) a portfolio company of the Rad Biomed Incubator Cardiology Cluster (both of Tel Aviv). VGS claims that within 5 years, 40% of vein grafts fail. The company has developed the Venous External Scaffolding Technology (VEST), a novel CE-marked stent-like technology whose use reduces vein graft failure rates following heart bypass procedures. VEST stabilizes an engrafted vein, from an external approach, rather than the traditional stent-in-vessel system. Based on a randomized multi-center trial in top centers in the UK including John Radcliffe Oxford Medical Center, and the Royal Brompton and Harefield Hospitals (London), the VEST was granted CE approval in March 2013. Further trials are planned with leading heart centers in Europe in early 2014, complementing the planned launch of the VEST in Europe in 2Q14.
The conference also described imperfections of some IC treatments to date, and addressed associated complications of some of today's solutions. A whole session, for example, focused on coronary complications, with speakers' subjects ranging from "I truly did not expect this" to "But it looked like a perfect result..."or "TAVI complications: They took the valve for a walk". Furthering this acknowledgement of imperfections within the clinical environment, a number of presenting companies addressed the side-effects of today's treatments. Two companies that were awarded top places in the conference's competition (there has to be a competition, and an award ceremony!) were to reduce the side effects encountered while performing cardiovascular procedures.
Control Rad Systems (Radnor, Pennsylvania) has developed a patented system to reduce dramatically the radiation dose required to perform any fluoroscopic procedure, such as cardiac catheterization or TAVR. The system addresses a concern that exposure to radiation in substantially longer and more frequent procedures is impacting the health of patients, and placing physicians and staff at high risk of excess radiation. In the CRS system, the physician's gaze is tracked in real time, and the radiation dose is adjusted by a high speed dynamic collimator, in order to provide greater detail in the region of interest (eye-focus) and less in the peripheral field of view.
The company has recently demonstrated over 80% dose reduction by this means. "Partnerships have been signed with some of the leading companies in the field", Allon Guez, President, told MDD. Current investors in the company include Jennison Associates (New York) and the Mendham Investment Group (Mendham, New Jersey).Clear Catheter Systems (Bend, Oregon), received an award for their PleuraFlow product, a novel system that evacuates blood and fluid after surgery to speed recovery and improve patient outcomes in the ICU during the initial critical hours after heart surgery. PleuraFlow prevents chest tube clogging to minimize the problem of retained blood complications after heart surgery.
The company plans to expand use of its PleuraFlow Active Clearance Technology by hospitals and clinicians to improve recovery, implementing an easy to use bedside system that keeps evacuation devices optimally functioning in the post heart and thoracic surgery recovery period. The clearance loop is manipulated using a proprietary magnetically-coupled handle to enable clinicians to break up and clear obstructive clots without compromising the sterile environment inside the tube.