Menlo Park, CA, United States
Menlo Park, CA, United States

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Mazzaferri Jr. E.L.,Ohio State University | Gradinac S.,University of Belgrade | Sagic D.,University of Belgrade | Otasevic P.,University of Belgrade | And 6 more authors.
American Heart Journal | Year: 2012

Objectives: The aim of this study was to assess the feasibility, safety, and preliminary efficacy of a novel percutaneous left ventricular partitioning device (VPD) in patients with chronic heart failure (HF) and a prior anterior myocardial infarction. Background: Anterior myocardial infarction is frequently followed by left ventricular remodeling, HF, and increased long-term morbidity and mortality. Methods: Thirty-nine patients were enrolled in a multinational, nonrandomized, longitudinal investigation. The primary end point was an assessment of safety, defined as the successful delivery and deployment of the VPD and absence of device-related major adverse cardiac events over 6 months. Secondary (exploratory) efficacy end points included changes in hemodynamics and functional status and were assessed serially throughout the study. Results: Ventricular partitioning device placement was not attempted in 5 (13%) of 39 subjects. The device was safely and successfully implanted in 31 (91%) of the remaining 34 patients or 79% of all enrolled patients. The 6-month rate of device-related major adverse cardiac event occurred in 5 (13%) of 39 enrolled subjects and 5 (15%) of 34 treated subjects, with 1 additional event occurring between 6 and 12 months. For patients discharged with the device to 12 months (n = 28), New York Heart Association class (2.5 ± 0.6 to 1.3 ± 0.6, P <.001) and quality-of-life scores (38.6 ± 6.1 to 28.4 ± 4.4, P <.002) improved significantly; however, the 6-minute hall walk distance (358.5 ± 20.4 m to 374.7 ± 25.6 m, P nonsignificant) only trended toward improvement. Conclusions: The left VPD appears to be relatively safe and potentially effective in the treatment for patients with HF and a prior anterior myocardial infarction. However, these limited results suggest the need for further evaluation in a larger randomized controlled trial. © 2012 Mosby, Inc.


Costa M.A.,Case Western Reserve University | Pencina M.,Harvard University | Nikolic S.,CardioKinetix | Engels T.,CardioKinetix | And 2 more authors.
American Heart Journal | Year: 2013

Background Left ventricle (LV) remodeling after anterior wall myocardial infarction leads to increased LV volumes, myocardial stress, and, ultimately, heart failure (HF). Patients have high morbidity and mortality risk, and treatment remains limited. Percutaneous ventricular restoration (PVR) therapy using the Parachute device, a fluoropolymer membrane stretched over a nitinol conical frame, is a novel approach to partition off the damaged myocardium. In the European and United States PARACHUTE feasibility trials, the observed rates of death or rehospitalization for HF were <17% at 12 months. These data compare favorably with historical data and support the need of a randomized trial to determine the clinical efficacy of PVR on outcomes for patients with ischemic HF. Objective To determine the safety and efficacy of PVR utilizing a LV partitioning device, Parachute, in a randomized clinical trial compared with optimal medical therapy. Methods This US pivotal trial is approved by the Food and Drug Administration (ClinicalTrials.gov Identifier: NCT01286116) and will randomly assign (1:1) 478 patients with New York Heart Association class III-IV ischemic HF, akinetic or dyskinetic LV wall abnormality, and ejection fraction between 15% and 35% to optimal medical therapy (control) versus Parachute device implantation in approximately 65 hospitals. The primary endpoint is death or rehospitalization for worsening HF. Sample size calculation assumes constant hazards and follow-up ≥12 months using an event-driven trial design. Conclusions We reported the rational and design of the first multicenter randomized trial to test the efficacy of PVR using the Parachute device to treat patients with ischemic HF and dilated LV. © 2013 Mosby, Inc.


Patent
CardioKinetix | Date: 2012-06-04

Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.


Patent
CardioKinetix | Date: 2010-08-18

Described herein are handle covers (106) for use with one or more delivery catheters (102) that may be used to deliver and/or remove an expandable cardiac implant. A handle cover may be formed from two interlocking pieces, and may include a control adapter (110) that may be used to control release and/or attachment of an expandable implant. The control adapter may be configured to interact with an implant release control (104) on the delivery catheter. The control adapter may also be lockable to prevent unintended activation of the implant release control. The handle cover may be reusable or disposable (e.g., single-use). In general, the implant control may be shaped so that hit may be held by a doctor, technician or other user, and may facilitate access to various components of the delivery catheter, including one or more ports (e.g., vacuum/inflation ports, etc.).


Trademark
CardioKinetix | Date: 2011-11-22

Medical implants composed of artificial materials.


Trademark
CardioKinetix | Date: 2013-03-11

Surgical, medical, dental and veterinary apparatus and instruments, namely, artificial medical implants for the treatment of heart disease and failure; artificial limbs, eyes and teeth; orthopedic apparatus and instruments for diagnostic and therapeutic use; suture materials; medical implants composed of artificial materials.


Trademark
CardioKinetix | Date: 2012-05-29

Medical implants composed of artificial materials.


News Article | December 9, 2014
Site: www.xconomy.com

CardioKinetix, Inc. is developing new technology for treating Congestive Heart Failure (CHF). This is a catheter-based intervention implanted into the heart. CHF results from damage to the heart from several causes, which affects nearly five million people in the U.S.


News Article | February 28, 2013
Site: www.xconomy.com

CardioKinetix, Inc. is developing new technology for treating Congestive Heart Failure (CHF). This is a catheter-based intervention implanted into the heart. CHF results from damage to the heart from several causes, which affects nearly five million people in the U.S.

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