Medtronic Begins ENDEAVOR II DES Trial

On July 17, Medtronic, Inc. (Santa Rosa, CA) commenced ENDEAVOR II, the pivotal clinical trial for its Endeavor Drug-Eluting Stent. The trial will evaluate the safety and efficacy of the device, which is coated in ABT-578 (rapamycin), and compare results to Medtronic’s standard Driver stent. ENDEAVOR II will include approximately 1,200 patients enrolled at 96 hospitals in 21 countries, and its primary endpoint is target vessel failure at 9 months.

Medtronic also recently announced the European launch of its new Micro-Driver Coronary Stent, which is designed for small coronary arteries. According to Medtronic, the next-generation Micro-Driver stent is the first and only cobalt-based alloy, modular stent available in the EU for treating coronary artery disease in vessels with diameters from 2.25 mm to 2.75 mm. The Micro-Driver stent is part of the Driver family of stents, which will become the foundational stent for Medtronic’s drug-eluting stent program. The devices are approved in sizes that are 2.25, 2.5, and 2.75 mm in diameter, and in lengths of 8, 12, 14, 18, and 24 mm, in all countries in the EU. Medtronic expects to launch the Driver Coronary Stent in the US in the fall of 2003.

Cordis Issues Letter Regarding Thrombosis in Patients Treated with CYPHER

On July 7, Cordis Corporation (a Johnson & Johnson company, Miami, FL) sent an update letter to physicians and other health care professionals regarding the incidence of subacute thrombosis in association with CYPHER Coronary Stents and how best to prevent it. The letter states that Cordis has received a small number of adverse event reports of stent thrombosis occurring at the time of implantation or within a few days thereafter. The company believes that the rate of thrombosis may be impacted by such factors as: “failure to achieve adequate stent apposition (due to underdeployment) or suboptimal use of antiplatelet medication.” Cordis also notes that although there have been a small number of reported cases, the current SAT rate for the CYPHER Stent is between 0.1% and 0.5%, which is less than the current 1% to 2% rate for bare metal stents.

According to the letter, Cordis has learned that some interventionalists have been overexpanding smaller stents for use in larger-diameter vessels. To reduce the chance of thrombosis in patients treated with the CYPHER Stent, Cordis emphasizes the importance of selecting the appropriate stent size as well as appropriate patients, using an adequate antiplatelet regimen, and using the proper technique for stent deployment. This includes ensuring the stent is fully deployed and in contact with the vessel wall. Cordis also states that the lesion should be predilated with a PTCA catheter, and that the CYPHER Stent is not approved for direct stenting.

Bacchus Vascular Secures $25M in Funding

On July 8, Bacchus Vascular (Santa Clara, CA) announced it had raised $25 million in a Series D financing led by Warburg Pincus LLC. The company reports that since Thomas Fogarty, MD, founded the company in 1999, it has raised more than $40 million. The proceeds from the latest round of financing will be used to develop new products and commercialize and market existing product lines such as the Trellis Reserve drug-infusion catheter and the Solera mechanical thrombectomy device.

Volcano to Acquire JOMED’s IVUS and FM Businesses

Volcano Therapeutics, Inc. (Laguna Hills, CA) recently signed a letter of intent to acquire JOMED, Inc.’s (Beringen, Switzerland) global IVUS and Functional Measurement businesses. Of the acquisition, Scott Huennkens, President and CEO of Volcano Therapeutics, comments, ?The addition of JOMED’s state-of-the-art intravascular ultrasound imaging systems is exceptionally synergistic with Volcano’s Virtual Histology IVUS system, [which was] recently demonstrated at the International Paris Course on Revascularization. Volcano’s intravascular thermography catheter products will integrate well with the pressure catheter and flow wire interventional products of JOMED’s Functional Measurement business.?

Five days prior to Volcano’s announcement, JOMED filed an application to the SWX Swiss Exchange for the delisting of its shares.

EVA Corp Begins FDA Trial of Endoleak Solution

EVA Corporation (Bethesda, MD) has received FDA clearance to conduct initial human trial studies at three centers in the US for the Endostaple, a device the company developed to prevent the occurrence of endoleaks after AAA stent graft placement. The Endostaple is designed to address proximal attachment problems using a mechanical fastening system that penetrates the entire wall thickness. The company states that the device may make it possible to use unsupported grafts in the future.

FDA Approves Guidant’s MULTI-LINK VISION Stent

Guidant has announced the FDA approval of its MULTI-LINK VISION Coronary Stent System. The company states that the use of cobalt chromium alloy allows for a thinner strut design and a lower profile, which enables physicians to access challenging coronary blockages. The approval covers the MULTI-LINK VISION stent in 3.0-mm to 4.0-mm diameters and 8.0-mm to 28.0-mm lengths. Guidant expects to launch the device in Europe later this year.

Appeals Court Upholds Boston Scientific DES Decision

Boston Scientific Corporation (Natick, MA) recently announced that a US Court of Appeals has upheld a US District Court decision that agreements between Cook, Inc. (Bloomington, IN), and Guidant Corporation (Indianapolis, IN) violated a co-exclusive license agreement among Boston Scientific, Cook, and Angiotech Pharmaceuticals (Palo Alto, CA) regarding paclitaxel-coated stents. The court’s decision supports Boston Scientific’s claim that a 2001 agreement between Cook and Guidant, whereby Guidant would be able to sell paclitaxel-coated stents, violates the 1997 contract that gave Boston Scientific and Angiotech co-exclusive licensing rights to the technology. The court also reportedly refused Cook’s request to return the case to District Court for further proceedings.

Guidant to Discontinue ANCURE

In mid-June, Guidant Corporation (Indianapolis, IN) announced a settlement agreement between EndoVascular Technologies, Inc. (EVT), a Guidant subsidiary, and the US Department of Justice regarding the ANCURE ENDOGRAFT System. EVT will make a payment of $43.4 million and an additional $49 million civil settlement to the government. Guidant reports that EVT will also plead guilty to 10 felony counts, including nine for shipping misbranded products and one count of a former employee making false statements to the government. In the wake of this news, Guidant earlier this week announced plans to discontinue the ANCURE product line.

Regarding the discontinuation, Guidant states that it “will ship product and provide support to implanting ANCURE physicians and their patients through October 1, 2003. Beyond that date, the company will continue to support implanted patients and physicians for long-term follow-up and device tracking needs.” Outside of these functions, EVT will cease ongoing operations, and the majority of affected employees will be offered positions within Guidant. The company emphasized that no patient with the ANCURE implant is at risk as a result of this matter.

FDA Approves Boston Scientific’s FilterWire EX, Cutting Balloon Ultra²

Boston Scientific Corporation (Natick, MA) last week received significant marketing approvals in both the US and Europe. The company’s FilterWire EX Embolic Protection System for the treatment of saphenous vein graft disease was granted FDA 510(k) clearance. Boston Scientific plans to launch the product in the US next week and states that it is the first filter-based system approved for this indication in the US. In 2001, the FilterWire EX system received the CE Mark for use in peripheral, coronary, and carotid vessels.

The company also received both FDA and CE Mark approval for its Cutting Balloon Ultra2 microsurgical dilatation device, designed for use in coronary arteries. Tiny, longitudinally mounted atherotomes help reduce a lesion’s resistance to expansion, relieving stress in the artery as the balloon inflates and reducing the force needed to expand the vessel. Monorail and over-the-wire versions of the device will be launched in both markets immediately.

Cook Launches Zenith AAA Graft

On May 23, Cook Incorporated (Bloomington, IN) received FDA clearance to sell its Zenith AAA Endovascular Graft System in the US. The approval came less than 2 months after the FDA’s Public Advisory Circulatory System Devices Panel gave its unanimous recommendation for the device. Cook reports that more than 1,000 US physicians have already registered for the training required to implant the Zenith, which has been commercially available outside the US for several years. “We expect a similar adoption curve in the US to what we’ve experienced overseas,” says David Biggs, Director of Advanced Technology Management for Cook. “Once physicians become aware of the potential benefits inherent in the Zenith design, a very large number of them decide to adopt this technology for most, if not all, of their AAA patients.” The company states that US sales will commence immediately. 

After Strong 6-Month DES Results, Guidant Pays Biosensors $10M

Guidant Corporation (Indianapolis, IN) recently made a $10 million milestone payment to Biosensors International (Singapore) based on the 6-month clinical data from FUTURE I, the first everolimus-eluting stent trial. Guidant states that the milestone is based on final adjudication of the 6-month MACE rate being equal to or less than the metallic stent in the control arm; these results were presented at the Paris Course on Revascularization in May.