Giday S.,Center for Digestive Health |
Van Alstine W.,Purdue University |
Van Vleet J.,Purdue University |
Ducharme R.,Cook Endoscopy |
And 5 more authors.
Digestive Diseases and Sciences | Year: 2013
Background: Non-variceal upper gastrointestinal (UGI) bleeding is a common condition that requires prompt lifesaving therapy and traditional endoscopic treatments require high technical proficiency to perform. Aims: This study was conducted to identify any local or systemic histopathologic effects of a hemostatic powder in a porcine model of active, severe, non-variceal UGI hemorrhage. Methods: This prospective, non-blinded animal study was performed in accordance with Good Laboratory Practice and Animal Care and Use Guidelines. Six animals underwent gastrotomy and creation of a looped vascular bundle, which was placed into the stomach lumen. The transplanted vascular bundle was punctured with an endoscopic needle-knife to create Forrest grade Ia or Ib bleeding. The hemostatic powder was then applied until hemostasis was achieved. Results: Initial hemostasis was achieved in all animals. Results of pre- and post-treatment coagulation studies were similar. All animals survived at least 9 days post-procedure. The hemostatic powder was not found in any local, regional, or systemic tissues. Gross and histologic analysis of systemic organs showed no infarct, particulate, or embolic effects. No gross or microscopic necropsy findings were treatment-related. Conclusions: The hemostatic powder achieved initial hemostasis (even in animals with spurting arterial bleeding) with no bowel obstruction or unintended luminal effects, no local or regional particulate effects, no systemic embolic effects, and no systemic coagulopathic effects. © 2013 Springer Science+Business Media New York.
Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: Twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study
Dake M.D.,Stanford University |
Scheinert D.,Park Hospital |
Tepe G.,Klinikum Rosenheim |
Tessarek J.,St Bonifatius Hospital |
And 7 more authors.
Journal of Endovascular Therapy | Year: 2011
Purpose: To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov). Methods: The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites. Results: Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5682.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months. Conclusions: These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy. © 2011 by the International Society of Endovascular Specialists.
Johnson B.M.,Purdue University |
Ko J.C.,Purdue University |
Hall P.J.,Cook Biotech Incorporated |
Saunders A.T.,MED Institute Incorporated |
Lantz G.C.,Purdue University
Journal of Surgical Research | Year: 2011
Background: Porcine small intestinal submucosa (SIS) is used as a biological implant for abdominal wall hernia repair to facilitate wound healing and augment local tissue strength. This prospective, randomized, blinded study evaluated local pain control provided by bupivacaine adsorbed to SIS for repair of acutely created abdominal wall full thickness muscle/fascial defects in ferrets. Materials and Methods: Eighteen healthy ferrets were randomly and equally assigned to three groups: (1) SIS with bupivacaine subjected to surgery, (2) SIS with no bupivacaine subjected to surgery, and (3) anesthesia only control group. Ferrets in groups 1 and 2 were anesthetized with butorphanol and sevoflurane for the surgery. Control ferrets were anesthetized in the same fashion for the same duration without surgery. Behavior and pain were evaluated in all ferrets by behavioral observation, algometer, and palpometer measurements, and heart and respiratory rates each obtained before surgery and at various intervals for 96 h after surgery. When pain reached a predetermined threshold, buprenorphine was used as a rescue analgesic. The serum and combined tissue concentrations of bupivacaine were analyzed. Results: Overall, the palpometer testing was better tolerated in the bupivacaine treated SIS group than by the untreated SIS group (P = 0.04). There was an observed physiologically significant difference in algometer and other palpometer readings as well as heart and respiratory rates. All ferrets in the untreated SIS group were rescued while 33% of the SIS-bupivacaine groups were rescued (P < 0.01). Peak serum concentrations of bupivacaine were in the range of 0.7 μg/mL with tissue level below detection levels and no clinical signs of toxicity were observed. Conclusions: Bupivacaine adsorbed to SIS provided some degree of pain relief over 2-4 days with no clinical adverse effects observed in the ferrets. © 2011 Elsevier Inc. All rights reserved.
Med Institute LLC | Date: 2010-07-13
The invention relates to medical device systems that include a delivery instrument comprising a sheath having an abluminal surface and a luminal surface; a radially-expandable frame disposed at least partially within the sheath, the frame having an abluminal surface at least partially in contact with the luminal surface of the sheath, and a luminal surface defining a sub-stantially cylindrical lumen; and a fine powder coating disposed on at least one of the abluminal surface of the frame and the luminal surface of the sheath. The invention also relates to methods of manufacturing, loading, and delivering the coated medical devices.
Steurer J.A.,Purdue University |
Lantz G.C.,Purdue University |
Kazacos E.A.,Purdue University |
Saunders A.T.,MED Institute Incorporated |
Altizer A.M.,Cook Biotech Incorporated
Journal of Investigative Surgery | Year: 2011
Background. Small intestinal submucosa (SIS) body wall defect repair in preclinical studies results in host tissue that resembles original host tissue histologically and has adequate strength to maintain repair integrity. However, these studies have been performed using acute hernia models that may not represent healing in a naturally occurring hernia. Methods. Fifty-four male SpragueDawley rats were divided into nine groups (n = 6) and fascia/muscle/peritoneal abdominal wall defects were created. One control group had no surgery. Four surgery groups had defects repaired immediately by (1) fascia suture apposition, (2) polypropylene mesh (PPM) peritoneal onlay, (3) SIS inlay, or (4) SIS peritoneal onlay. After defect creation, chronic hernias matured for 28 days, and then were similarly repaired. Follow-up after hernia repair for all groups was 28 days. Gross evaluation for hernia recurrence, infection, and adhesions was followed by histopathology and tensile testing of the repair. Results. There were no recurrent hernias or infection. Adhesions covered all implants. Histopathologic findings of inflammation and fibrosis were similar between all groups. There were no significant differences in tensile strength between SIS and PPM healing/incorporation or between acute and chronic hernia groups. Normal body wall was stronger than all repairs. Fascia closure in chronic hernias was stronger than acute fascia closure (p < .01). Conclusions. We found no significant differences between SIS and PPM healing/incorporation as determined by gross and histopathology and tensile strength testing. The study suggests that preclinical testing of abdominal body wall reconstruction in the rat may be adequately performed in acute studies. © 2011 Informa Healthcare USA, Inc.