WASHINGTON, Oct. 22 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT - News) today announced continued positive results from ABSORB, the world's first clinical trial evaluating the safety and performance of a fully bioabsorbable drug eluting stent platform for the treatment of coronary artery disease. One-year results from the first 30 patients in the trial demonstrated no stent thrombosis and a low major adverse cardiac event (MACE) rate at 12 months (1 patient, 3.4%, n=29), with no additional MACE, including no re-treatment of a diseased lesion (ischemia-driven target lesion revascularization) since six months for patients who received a bioabsorbable stent. The overall MACE rate in the ABSORB trial at six months was 3.3%, as previously announced in March 2007. The results were presented today at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

"We continue to see consistent positive data from consecutive patient follow-up in the ABSORB trial," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study. "Abbott's bioabsorbable coronary artery stent technology has maintained initial safety and effectiveness results in patients out to one year."

Abbott is the only company with a bioabsorbable drug eluting coronary stent in clinical trials. Abbott's bioabsorbable everolimus eluting coronary stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, Abbott's bioabsorbable stent is designed to restore blood flow by propping a clogged vessel open, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.

As reported in March 2007, late loss, a measure of reduction in lumen (vessel) diameter after stenting, was 0.44 mm for ABSORB at six months.

"ABSORB is an exciting future generation device that has the potential to advance the treatment of coronary artery disease beyond the benefits that next-generation metallic drug eluting stent platforms can provide," said John M. Capek, PhD., executive vice president, Medical Devices, Abbott. "Positive data with Abbott's bioabsorbable technology is encouraging and supports the direction we are moving toward in helping physicians open blocked arteries with stents, while also allowing the stent itself to disappear over time."

Abbott must have licensed the PLA bioabsorbable polymer from BIG. The drug Everolimus was licenseed from BIG. All the technology licenseed out and see others doing well, none of BIG's own flagship product can get regulatory approvals to start commercialisation. What a frustration! Notice JNJ didn't put up anything new and spectacular at TCT2007? Because JNJ don't have any good new weapon in hand.

 

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE:MDT - News), announced today that it has received CE (Conformité Européene) Mark approval for the commercial sale of the Endeavor^® Resolute Drug-Eluting Coronary Stent and plans to launch the product outside the United States earlier than originally projected.

The Endeavor Resolute stent will be launched in more than 50 countries in Europe, Asia, the Middle East and Africa by the end of 2007 ? making Medtronic the first company to offer two internally developed drug-eluting stent options for the treatment of coronary artery disease, a condition affecting millions of people worldwide. The new stent is not approved in the United States.

Endeavor Resolute adds an innovative new drug-eluting stent to Medtronic?s international stent portfolio, which also includes the Endeavor drug-eluting stent and the Driver^® bare-metal stent. The expanded portfolio provides physicians with a greater variety of stent choices to cover a wide range of patient needs.

Endeavor Resolute uses a proprietary new biocompatible polymer called BioLinx^?. The BioLinx polymer is designed to confer the same biocompatibility as the Endeavor stent?s phosphorylcholine (PC) polymer while extending the duration of drug exposure in the vessel. Developed by Medtronic scientists, BioLinx is the first polymer created specifically for use on a drug-eluting stent. The BioLinx polymer features a unique blend of hydrophilic and hydrophobic elements for optimal performance. Extensive preclinical studies have established the biocompatibility and drug delivery capabilities of the BioLinx polymer.

Prof. Patrick W.J.C. Serruys of the Heartcenter Rotterdam in The Netherlands performed the first commercial implant of the Endeavor Resolute stent on October 10. ?We now have a new drug-eluting stent for our patients with a breakthrough in coating technology,? said Prof. Serruys. ?This new BioLinx polymer has been fully assessed, both on biological and pharmacological parameters, and found to be compatible with blood, endothelial and smooth muscle cells.?

Prof. Serruys added: ?Endeavor Resolute provides the excellent safety profile of the Endeavor stent with extended delivery of the drug zotarolimus. To further evaluate the safety and efficacy of the new stent in real-world clinical practice, we have designed a post-market European study involving more than 2,300 patients.?

Patients treated with the Endeavor Resolute stent in the initial RESOLUTE clinical trial required no repeat procedures through nine months and had experienced no protocol-defined stent thrombosis through 12 months of follow-up. In-stent late lumen loss at nine months, the study?s primary endpoint, was met at 0.22 mm ± 0.27 mm, providing assurance of vessel healing in the targeted range while preventing repeat procedures. Among the trial?s 130 patients, only one required clinically-driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR) through 12 months. The incidence of major adverse cardiac events was 8.5 percent through 12 months.

The 12-month results from the RESOLUTE trial are available at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, DC, in abstract TCT-397. ?The RESOLUTE clinical results are impressive considering the enrolled patients presented with especially complex and challenging characteristics,? explained the trial?s principal investigator, Prof. Ian Meredith of Monash Medical Centre in Melbourne, Australia. These patients on average had longer lesions at 15.5 mm, and 82 percent of the patients were classified as having very complex lesions.

?Endeavor Resolute continues to deliver impressive clinical outcomes,? said Prof. Meredith. ?The stent?s drug-and-polymer combination has successfully reduced restenosis in a particularly challenging patient group while maintaining an excellent safety profile.?

Medtronic plans additional clinical trials of the Endeavor Resolute stent as part of a comprehensive program to characterize the stent?s long-term safety and efficacy in a variety of patient populations. The program will enroll approximately 13,000 patients in a series of randomized controlled trials and registries in the United States and internationally.

Endeavor Resolute leverages the strengths of the Endeavor drug-eluting stent, which was launched in Europe in July 2005 and is now available in more than 100 countries outside the United States. They share the same cobalt alloy stent platform, which provides excellent radial strength and conformability to the vessel wall, and both use the non-cytotoxic drug zotarolimus. Both of Medtronic?s drug-eluting stents also use highly biocompatible polymers.

?The Endeavor Resolute drug-eluting stent and the novel BioLinx polymer represent two important achievements of our robust product pipeline and demonstrate our commitment to innovation in interventional cardiology,? said Scott Ward, president of the CardioVascular business at Medtronic. ?With the combination of Driver, Endeavor and Endeavor Resolute, Medtronic is delivering safe and effective options for physicians to treat a broad range of patients with coronary artery disease.?

NATICK, Mass., and WASHINGTON, Oct. 22 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX - News) today welcomed results from the SPIRIT III Clinical Trial, which continue to support the proven safety and efficacy of the market-leading TAXUS® Express2(TM) Paclitaxel-Eluting Coronary Stent System and add to the growing body of strong clinical evidence for the XIENCE(TM) V (PROMUS(TM)) Everolimus Eluting Coronary Stent System. An analysis of the data was presented by Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation in New York, and the Principal Investigator of the SPIRIT III Trial, during a late- breaking trial session at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

One-year results from the SPIRIT III trial included an updated analysis of 1,002 patients with coronary artery disease treated with either the XIENCE V (PROMUS) Stent or the TAXUS Express Stent. Ischemia-driven target lesion revascularization (TLR) for 669 patients treated with the XIENCE V (PROMUS) Stent changed from 2.6% to 3.3% between nine months and one year, while for the 333 patients treated with the TAXUS Stent, TLR changed from 5.0% to 5.6% during the same time period, still failing to reach statistical significance (p=0.09). Target vessel revascularization (TVR) at one year was also similar, with 6.1% for PROMUS and 7.5% for TAXUS (p=0.41).

The overall MACE (Major Adverse Cardiac Events) rate (defined as cardiac death, myocardial infarction (heart attack, or MI) or ischemia-driven TLR) through one year was 5.8% for the XIENCE V (PROMUS) Stent and 9.9% for the TAXUS Stent (p=0.01), reflecting an increased number of small (non-Q wave) MIs at the time of the procedure (2.5% vs. 3.8%).

Subset analysis showed especially strong performance of the TAXUS Stent in diabetic patients with MACE rates remaining low at 4.7%, while MACE rates increased in the XIENCE V (PROMUS) Stent to 8.8%. In long lesions (lesion length>13.2 mm), MACE was 7.7% for the XIENCE V (PROMUS) Stent and 8.0% for the TAXUS Stent; in small vessels (RVD< / =2.775 mm), 6.1% for the XIENCE V (PROMUS) Stent and 12.1% for the TAXUS Stent*.

Stent thrombosis rates through one year were also low for both the TAXUS Stent (0.6%, 0.6%) and the XIENCE V (PROMUS) Stent (0.8%, 1.1%), using protocol and ARC definitions, respectively.

"The SPIRIT III one-year data reaffirms the proven long-term outcomes of the TAXUS Stent," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "We look forward to launching the PROMUS Stent in the U.S., which will complement our paclitaxel-eluting TAXUS Stent by offering physicians a deliverable Olimus option."

The PROMUS Stent has CE Mark approval and is distributed in most European countries and other international markets. The PROMUS Stent is an investigational device in the U.S. and not yet approved for sale. It is currently under FDA review with an anticipated U.S. launch in 2008. The safety and efficacy of the TAXUS Express2 Stent System have not been established in patients with diabetes, long lesions and small vessels.

SPIRIT is sponsored by Abbott. TAXUS, Express2 and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.