One, two, three, four, five - European DES market comes alive

After months of speculation and market anticipation, Medtronic has finally received European approval for its Endeavor (DES) system. The Endeavor stent, which has been subject to numerous delays and industry rumours, received the CE mark at the end of July 2005. Dr Jean Fajadet, Clinique Pasteur Unite de Cardiologie Interventionnelle, Toulouse, France, and one of the co-principal investigators of the ENDEAVOR II pivotal trial, said that the results from the ENDEAVOR trials have been both comprehensive and positive. Fajadet said, "I have had experience with each of the drug-coated stents on the market, and I believe that physicians in the European Union and elsewhere around the world will find that Endeavor represents an excellent course of treatment for their patients."

However, Medtronic was not the only company celebrating entry onto the lucrative DES market. Biosensors International's Netherlands-based subsidiary, Occam International B.V., has also received the CE mark for its Axxion DES, a polymer-free system. "We had expected to receive the CE approval for Axxion in the second half of 2005," commented Mr Yoh-Chie Lu, CEO and Chairman of Biosensors, "We are elated to receive this approval now, barely one month into our expected time period."

Endeavor

The Endeavor DES incorporates the Rapid Exchange delivery system. According to the company, the Endeavor system, the first cobalt alloy platform on the DES market, offers best-in-class deliverability, excellent clinical results and a strong patient safety profile.

The Endeavor system combines the Driver bare-metal stent with a Sirolimus-analogue drug, known as ABT-578, and a biocompatible polymer, called PC Technology, to treat coronary artery disease. ABT-578 is a unique, patented compound licensed to Medtronic by Abbott Laboratories and is designed to inhibit the cellular process that leads to restenosis. Medtronic also licenses Abbott's proprietary phosphorylcholine polymer coating technology (PC Technology), which is licensed under patents owned by Biocompatibles. PC Technology is designed to serve as the "delivery matrix," which controls the elution, or release, of ABT-578 directly into the arterial wall.

An enthusiastic Scott Ward, President of Medtronic Vascular commented, "We are very pleased to provide physicians and patients with Medtronic's high performance Endeavor drug-eluting stent system."

Ward added, "Physicians will now have a broader choice among the drug-eluting stents that are available to treat their patients. We believe the Endeavor system offers a powerful combination of deliverability, efficacy and safety that is unmatched by any other commercially available stent." Medtronic plans to conduct a simultaneous worldwide launch in approximately 40 countries outside the US.

Medtronic has reported strong clinical results in the ENDEAVOR II clinical trial, including a 47% reduction in Target Vessel Failure (TVF), the study's primary endpoint, between the Endeavor arm and the control group. It also demonstrated a 62% reduction in Target Lesion Revascularization (TLR). Safety data from the ENDEAVOR II study indicated a 50% reduction in the Major Adverse Cardiac Event (MACE) rate compared to a conventional bare-metal stent, and just a 0.5% rate of stent thrombosis at 30 days, with no late thrombosis beyond 30 days and no late stent malapposition.

Medtronic will report results of the ENDEAVOR III trial at the Transcatheter Cardiovascular Therapeutics meeting in October. The company is still conducting clinical trials in the US and does not expect to have the device on the US market until 2007. Enrolment in Endeavor IV is expected to be completed by April 2006 and data will be submitted to the FDA for approval by mid-2006.

Axxion

Meanwhile, Biosensors' Axxion DES incorporates the company's Calix stent delivery system and the commercially available drug, paclitaxel. The drug is directly coated on the stent over a layer of glycocalix, a substrate designed to improve biocompatibility of the metal stent surface after the drug is released. Calix is an inert, permanent coating which covers the whole stent of the company's NexusII+ stent. The Calix underlayer prevents inflammation, platelet activation and immunological responses and facilitates re-endothelisation through biomimicry and the endothelial surface.

This technology is licensed exclusively by Occam from a privately-held company in Germany that is a leading designer and manufacturer of ultra-thin coatings that set unsurpassed standards of efficiency, hemocompatibility and biocompatibility.

The Axxion stent is delivered by the Senso balloon catheter, specially designed for stent delivery. Its PTFE-coated hypotube and semi-compliant balloon made of Occam's proprietary CR30/1 polymer with two radiopaque markers ensure excellent performance. The stent's LubriLAST hydrophilic coating together with a low-friction innerlumen, soft balloon tip and slim profile (<1.1mm) assures excellent pushability, trackability and crossability.

Biosensors expects sales of Axxion to contribute to the Group's revenue for the current financial year ending March 2006 prior to receiving regulatory approval of its flagship DES system, BioMatrix, for which it filed for the CE mark in April 2005. The BioMatrix DES system incorporates the Group's proprietary anti-restenotic drug, Biolimus A9, bioresorbable polymer, S-Stent and sensostent delivery catheter, all of which have been developed in-house.

"In anticipation of the CE mark, we have already ramped up our manufacturing and marketing preparedness. We are operationally ready to launch Axxion in selected markets, which is an essential part of our long-term strategy to have the commercialisation of our own DES products drive the Group's future revenues," said Steve Thomson, Chief Operating Officer, Biosensors International.

The worldwide market for DES is estimated at $5.5 billion and growing rapidly. Currently, Cordis and Boston Scientific dominate the worldwide DES market. Outside of the US, excluding Japan, the market is estimated to be worth to be between $1 billion and $1.5 billion. Ward believes the company will exceed the 15% market share within 12 months and that Endeavor sales will be between $30 million to $50 million per quarter for the next four quarters.

Medtronic believes its Endeavor is easier for doctors to use than those currently on the market and has a good safety profile. As a result, they are expecting many doctors to switch from Cordis' Cypher stent or Boston Scientific's Taxus stent.

Meanwhile at EuroPCR, Biosensors had further reasons to be pleased as the company revealed data from its STEALTH study, which is analysing the company's BioMatrix DES system. Also at EuroPCR, Sorin announced the results from its JUPITER II study examining the company's Janus Tacrolimus-eluting Carbostent, and not to be outdone, Conor MedSystem's revealed further results from it EuroSTAR trial, designed to study it's CoStar DES stent.

There was also news from Terumo Europe, who announced that the first patient has been enrolled in the NOBORI 1 DES clinical trial, an equivalency study that will compare Terumo's Nobori DES to Boston Scientific's Taxus Express2 stent. Also, German company OrbusNeich announced the six-month results from its HEALING II study, which is evaluating the Bio-engineered Genous stent. The company claims this stent system is unique as it does not elute or carry any drug, but nevertheless, minimises restenosis, while offering an additional safety profile - immediate protection against thrombus.

In the mean time, Boston Scientific and Cordis resumed their battle in the courts at both sides of the Atlantic and at EuroPCR, where both claimed 'victories' and boasted 'positive results' from their latest round of litigation and trial results, respectively.