Medtronic's IN.PACT Clinical Program Presented at TCT

September 28, 2010—Medtronic, Inc. (Minneapolis, MN) announced the latest results from the In.Pact coronary drug-eluting balloon (DEB) clinical program that were presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC.

Professor Bruno Scheller, MD, presented 6-month final results of the investigator-initiated IN.PACT CORO ISR study on coronary in-stent restenosis. Prof. Scheller also presented an overview of the FreePac technology and interim findings from the larger IN.PACT clinical program, which includes studies of both coronary and peripheral applications of the IN.PACT family of drug-eluting balloons. Details of the In.Pact studY for treating the superficial femoral artery are provided in the Endovascular Today news coverage of TCT.



“Based on a growing body of clinical data and while results of randomized trials are awaited, IN.PACT drug-eluting balloons show great promise for the treatment of both coronary and peripheral artery disease,” commented Professor Scheller. “The best potential applications appear to be in atherosclerotic leg vessels and for previously stented coronary arteries that have restenosed. Drug-eluting balloons may very well become the fourth therapeutic platform for cardiovascular interventions, joining traditional balloon angioplasty, bare-metal stents, and drug-eluting stents.”



According to Professor Scheller, In.Pact drug-eluting balloons feature the company's FreePac hydrophilic coating that frees and separates paclitaxel molecules, facilitating their absorption into the vessel wall to mitigate renarrowing of the artery over time. The IN.PACT clinical program consists of studies on the treatment of de-novo coronary lesions and coronary in-stent restenosis. A combination of company-sponsored and physician-initiated studies, it will enroll a total of approximately 1,500 patients.



At TCT, Prof. Scheller highlighted IN.PACT CORO ISR, a single-center, single-arm confirmatory study of the In.Pact Falcon DEB for the treatment of coronary in-stent restenosis conducted in 23 consecutive patients with a total of 26 lesions. The primary endpoint was late lumen loss measured by angiographic follow-up at 6 months. In the study, in-stent late lumen loss with the In.Pact Falcon DEB was 0.07 mm at 6 months, indicating a minimal degree of tissue growth inside the stented segment of the treated vessel, the company stated.