title: Acute and 16-month outcomes of a new stent: the first-in-man evaluation of the Medtronic S9 (integrity) stent.
abstract: OBJECTIVE
  A first-in-man evaluation of the safety, feasibility, deliverability, and efficacy of the new Medtronic S9 (Integrity) bare metal stent (BMS) in complex coronary diseases.
  
  
  BACKGROUND
  Excellent deliverability remains an unmet clinical need among stents especially in complex lesions. The S9 (Integrity) BMS utilizes a new, continuous sinusoidal manufacturing technology to enhance stent flexibility and deliverability, without sacrificing radial strength.
  
  
  METHODS
  This is a first-in-man, open label observational study in 15 patients treated with S9 (Integrity) BMS. Device success during implantation, clinical outcomes, 30-day and 12-month device-oriented and patient-oriented composite efficacy end-points, and 16-month angiographic restudy were evaluated (with amended protocols).
  
  
  RESULTS
  Thirty-four stents were deployed to treat 30 complex lesions. Mean lesion length was 22.93 ± 11.78 mm, and mean percentage diameter stenosis was 78.59% ± 9.01%. Mean stent delivery time was 125 ± 68.3 sec. Acute device, lesion, and procedure success, as defined, were 100%. Device-oriented and patient-oriented composite end-points were zero at 30 days. Two patients had ischemic driven revascularization before 12 months. One patient had non-cardiac death at 13 months; all remaining 12 patients received 16 months angiographic restudy and only one had angiographic restenosis. The mean diameter of stenosis was 27.0% ± 18.3%, and mean late loss was 0.73 ± 0.50 mm. Total target vessel failure rate was 21.4% (3/14) at 16 months.
  
  
  CONCLUSIONS
  The new S9 (Integrity) BMS exhibited excellent deliverability, flexibility, and conformability, contributing to good acute and 16 months outcomes in complex cases.
authors.affiliation: Division of Cardiology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China. drsl@i-cable.com
authors.forename: Stephen Wai Luen
authors.initials: SW
authors.lastname: Lee
authors.forename: Michael P H
authors.initials: MP
authors.lastname: Chan
authors.forename: Kelvin K W
authors.initials: KK
authors.lastname: Chan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006723:Hong Kong; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D011474:Prosthesis Design; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals