Safety and biocompatibility of the myosplint system - A passive implantable device that alters ventricular geometry for the treatment of heart failure

Chad Hamner, George Ruth, Marc Raffe, Frederick J. Schoen, Hartzell V Schaff

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

A passive implantable device developed for the treatment of heart failure, the Myosplint® System, has demonstrated therapeutic efficacy in a canine model of pacing induced heart failure. The current study sought to demonstrate chronic device safety and biocompatibility, in vivo, in a normal porcine model. Two devices were implanted into each normal, beating heart of 6 juvenile and 15 adult pigs without cardiopulmonary bypass. Animals survived 90 (juvenile and adult) or 180 days (adult only). Serial hematologic and biochemical profiles were evaluated in each pig during the study period. A comprehensive necropsy study was performed in each pig to evaluate device stability, healing response, thromboembolism, hemorrhage, and intravascular hemolysis related to the Myosplint system. Six adult animals died from infectious disease (four) or perioperative (two) complications unrelated to device design or function and were excluded from the final analysis. No clinical, biochemical or pathologic evidence of significant, device related adverse events was observed in surviving animals. The chronic myocardial healing response appeared normal at term, and all devices maintained their structural integrity throughout the study. The Myosplint system was easily implanted in beating hearts and was rapidly incorporated into host tissues without clinically significant morbidity in this porcine model.

Original languageEnglish (US)
Pages (from-to)438-443
Number of pages6
JournalASAIO Journal
Volume50
Issue number5
DOIs
StatePublished - Sep 2004

Fingerprint

Treatment Failure
Biocompatibility
Swine
Heart Failure
Safety
Equipment and Supplies
Animals
Geometry
Safety devices
Equipment Safety
Structural integrity
Equipment Design
Thromboembolism
Hemolysis
Cardiopulmonary Bypass
Communicable Diseases
Tissue
Canidae
Hemorrhage
Morbidity

ASJC Scopus subject areas

  • Biophysics
  • Bioengineering

Cite this

Safety and biocompatibility of the myosplint system - A passive implantable device that alters ventricular geometry for the treatment of heart failure. / Hamner, Chad; Ruth, George; Raffe, Marc; Schoen, Frederick J.; Schaff, Hartzell V.

In: ASAIO Journal, Vol. 50, No. 5, 09.2004, p. 438-443.

Research output: Contribution to journalArticle

@article{608ebd4967aa4a55862fc351f2a8728d,
title = "Safety and biocompatibility of the myosplint system - A passive implantable device that alters ventricular geometry for the treatment of heart failure",
abstract = "A passive implantable device developed for the treatment of heart failure, the Myosplint{\circledR} System, has demonstrated therapeutic efficacy in a canine model of pacing induced heart failure. The current study sought to demonstrate chronic device safety and biocompatibility, in vivo, in a normal porcine model. Two devices were implanted into each normal, beating heart of 6 juvenile and 15 adult pigs without cardiopulmonary bypass. Animals survived 90 (juvenile and adult) or 180 days (adult only). Serial hematologic and biochemical profiles were evaluated in each pig during the study period. A comprehensive necropsy study was performed in each pig to evaluate device stability, healing response, thromboembolism, hemorrhage, and intravascular hemolysis related to the Myosplint system. Six adult animals died from infectious disease (four) or perioperative (two) complications unrelated to device design or function and were excluded from the final analysis. No clinical, biochemical or pathologic evidence of significant, device related adverse events was observed in surviving animals. The chronic myocardial healing response appeared normal at term, and all devices maintained their structural integrity throughout the study. The Myosplint system was easily implanted in beating hearts and was rapidly incorporated into host tissues without clinically significant morbidity in this porcine model.",
author = "Chad Hamner and George Ruth and Marc Raffe and Schoen, {Frederick J.} and Schaff, {Hartzell V}",
year = "2004",
month = "9",
doi = "10.1097/01.MAT.0000136506.34082.76",
language = "English (US)",
volume = "50",
pages = "438--443",
journal = "ASAIO Journal",
issn = "0162-1432",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - Safety and biocompatibility of the myosplint system - A passive implantable device that alters ventricular geometry for the treatment of heart failure

AU - Hamner, Chad

AU - Ruth, George

AU - Raffe, Marc

AU - Schoen, Frederick J.

AU - Schaff, Hartzell V

PY - 2004/9

Y1 - 2004/9

N2 - A passive implantable device developed for the treatment of heart failure, the Myosplint® System, has demonstrated therapeutic efficacy in a canine model of pacing induced heart failure. The current study sought to demonstrate chronic device safety and biocompatibility, in vivo, in a normal porcine model. Two devices were implanted into each normal, beating heart of 6 juvenile and 15 adult pigs without cardiopulmonary bypass. Animals survived 90 (juvenile and adult) or 180 days (adult only). Serial hematologic and biochemical profiles were evaluated in each pig during the study period. A comprehensive necropsy study was performed in each pig to evaluate device stability, healing response, thromboembolism, hemorrhage, and intravascular hemolysis related to the Myosplint system. Six adult animals died from infectious disease (four) or perioperative (two) complications unrelated to device design or function and were excluded from the final analysis. No clinical, biochemical or pathologic evidence of significant, device related adverse events was observed in surviving animals. The chronic myocardial healing response appeared normal at term, and all devices maintained their structural integrity throughout the study. The Myosplint system was easily implanted in beating hearts and was rapidly incorporated into host tissues without clinically significant morbidity in this porcine model.

AB - A passive implantable device developed for the treatment of heart failure, the Myosplint® System, has demonstrated therapeutic efficacy in a canine model of pacing induced heart failure. The current study sought to demonstrate chronic device safety and biocompatibility, in vivo, in a normal porcine model. Two devices were implanted into each normal, beating heart of 6 juvenile and 15 adult pigs without cardiopulmonary bypass. Animals survived 90 (juvenile and adult) or 180 days (adult only). Serial hematologic and biochemical profiles were evaluated in each pig during the study period. A comprehensive necropsy study was performed in each pig to evaluate device stability, healing response, thromboembolism, hemorrhage, and intravascular hemolysis related to the Myosplint system. Six adult animals died from infectious disease (four) or perioperative (two) complications unrelated to device design or function and were excluded from the final analysis. No clinical, biochemical or pathologic evidence of significant, device related adverse events was observed in surviving animals. The chronic myocardial healing response appeared normal at term, and all devices maintained their structural integrity throughout the study. The Myosplint system was easily implanted in beating hearts and was rapidly incorporated into host tissues without clinically significant morbidity in this porcine model.

UR - http://www.scopus.com/inward/record.url?scp=4544242194&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=4544242194&partnerID=8YFLogxK

U2 - 10.1097/01.MAT.0000136506.34082.76

DO - 10.1097/01.MAT.0000136506.34082.76

M3 - Article

C2 - 15497382

AN - SCOPUS:4544242194

VL - 50

SP - 438

EP - 443

JO - ASAIO Journal

JF - ASAIO Journal

SN - 0162-1432

IS - 5

ER -