Medinol Moves Out Front

Disclosure: Dr. Leon reports stock options in Medinol. 

What is Medinol’s history in interventional cardiology?

Dr. Kobi Richter: Medinol was incorporated by myself and Dr. Judith Richter in 1994 as a stent company. After successful clinical trials in 1995, we teamed up with Boston Scientific Corporation to market our stents worldwide. We introduced the NIR stent in Europe in 1996 and in the United States in 1998, and captured the leading market share in both markets. We have continued to develop new generations of stents with the NIR^®, NIR Elite^™, NIROYAL^™ and NIRxcell^™, to name a few. After working with different partners, we built our own marketing and sales organization last year, and are now selling our stents in the U.S. and in Europe.

Dr. Leon, how did you come to work with Dr. Richter?

Dr. Marty Leon: I met Kobi early Saturday morning before a TCT session in 1994. He presented me with a concept for a new stent design that I felt was remarkably insightful and could be a breakthrough in the field. We agreed to work together — combining my clinical research and pre-clinical experiences with his unique understanding of medical device design and manufacturing — hoping to develop cardiovascular medical products, beginning with the NIR stent, which would benefit our patients.  The relationship has grown into a close friendship with enormous respect for the power of a close physician-engineer collaboration to create innovation.

Dr. Richter: Yes, I believe our long-lasting professional relationship is built on mutual respect of the professional commitment to marry technology with clinical expertise to bring optimal solutions to patients.

Why does Medinol stand out?

Dr. Richter: I believe that we are a unique company in the combination of in-house knowledge and expertise both technically and clinically. That combination allows us to develop the optimal devices to solve clinical needs with leading-edge technologies. 

Dr. Leon: From my experience working with Kobi and his colleagues, I believe that Medinol is differentiated for 3 reasons: (1) creative, insightful device designs which are usually ahead of the field; (2) an obsessive commitment to quality in manufacturing, which translates into consistent outcomes and improved patient safety; (3) a recognition that clinical evidence drives commercial adoption, which means well-conceived and carefully executed clinical research by an internal team with deep clinical expertise and engineering innovation.

How much room for innovation still exists with stents?

Dr. Leon: There is always room for additional innovation, even in the mature field of bare metal stents (BMS). Improved stent delivery is still an important consideration and the scaffolding quality is critical for patients receiving BMS. The recently launched NIRxcell BMS from Medinol has a unique design for superb scaffolding and introduces a revolutionary spring tip, improving the balance between pushability and flexibility. Medinol’s innovative manufacturing results in more cost-effective products, which have significant implications in an economically constrained environment.

Is there a need in the U.S. market for another drug-eluting stent (DES) manufacturer?

Dr. Leon:  In the U.S., we could definitely benefit from safer, more easily delivered and cost-effective DES solutions. We’ve learned that improved stent scaffolding and more biocompatible durable polymers will improve clinical outcomes and it’s reasonable to suppose that Medinol, with its flat-coated elastomeric DES (eDES), may present a best-in-class DES for the future.

What are Medinol’s plans for future stent innovation?

Dr. Richter:  We believe that the basic stent scaffolding features should not be ignored, especially in DES, where the stent remains in place after drug elution has ended. We also believe that any known non-metallic material cannot replace the advantages of metal stents. We are currently conducting a pivotal trial in the U.S. with a DES that we believe will have unparalleled deliverability and scaffolding combined with a unique elastomer that maintains higher polymer integrity than other stents in the market. Beyond that, we have another DES in development that has no carrier for the drug, hence would be left with an excellent non-thrombogenic profile after drug elution.

Is Medinol working on any technologies besides stents?

Dr. Leon: I have been working for the past several years with Medinol, through its subsidiary Valve Medical, under the direction of Kobi’s son Yoram, on a visionary transcatheter aortic valve replacement (TAVR) system, including an ultra-low profile (10-12 French) delivery system, a specialized frame design, a modular concept to dock the valve and the frame in situ, and an external coating to prevent paravalvular leak.  We expect to begin first human implants in the coming months and we are excited to see the typical Medinol innovation now applied to this important new field of transcatheter valve therapy.  

Dr. Richter: We have several subsidiaries, including Valve Medical. Our sensor subsidiary, Microtech, is developing a miniature passive sensor for chronic monitoring of pressure and other parameters that could be used to measure pulmonary pressure, portal vein pressure, brain ventricle pressure, and the like. We hope to soon bring to market a unique and effective system for opening chronic total occlusions called Piculet, which is already approved in Europe. Our subsidiary Biorest has developed a drug that when injected during stenting, reduced major adverse cardiac events in diabetics to the level of non-diabetics. We are also developing cutting-edge percutaneous transluminal coronary angioplasty balloons and peripheral stents.  So, we keep ourselves very busy.  

It seems as if you two have been close colleagues for a long time.  How do you work through your different perspectives and backgrounds as you collaborate?

Dr. Richter: It is not so much agreeing or disagreeing. Often, we have debated our respective professional views in a continuous attempt to solve clinical needs by providing a better technology. This process always starts with each bringing his strong ideas, and the magic happens when they combine in a harmonious synthesis to make a successful solution.

Dr. Leon: My relationship with Kobi encourages dynamic conversations on all subjects -— there are no sacred cows.  I tell him what I think is needed from a clinical perspective and he explains his thoughts on what can and can’t be accomplished from a technology standpoint. He was correct that vascular brachytherapy was a mistake, but I was further ahead in my thinking that we needed a definitive solution to restenosis, in the form of a DES. The jury is still out on the ultimate value of bioresorbable scaffolds — we need more data and less hype. But in the end, my incredible respect for Kobi’s genius as an innovator and the track record of Medinol as an ethical and forward-thinking commercial organization has fostered the special collaboration that hopefully will continue to benefit patients in the future.