SBIR-STTR Award

Improved Long-Term Biocompatibility of Coronary Stents by Plasma Coating Process
Award last edited on: 5/15/2020

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$4,617,195
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Meng Chen

Company Information

Nanova Inc

3806 Mojave Court
Columbia, MO 65202
   (573) 234-6451
   nanovainc@gmail.com
   www.nanovabio.com/
Location: Single
Congr. District: 04
County: Boone

Phase I

Contract Number: 1R44HL097485-01A2
Start Date: 9/1/2011    Completed: 2/29/2012
Phase I year
2011
Phase I Amount
$220,243
Improved long-term biocompatibility of coronary stents by plasma coating process Abstract Drug-eluting stents (DES) have been widely used to treat patients of cardiac disease due to their better ability to control restenosis than bare metal stents (BMS). However, a serious adverse outcome of late stent thrombosis in patients treated with DES has been reported, which leads to fatal heart attack and death even though it occurs at low rate. Thus, for safe and effective clinical use, a coronary stent needs to have better biocompatibility on its surface that will provide sufficient thrombo-resistance in addition to inhibiting cell proliferation thereby slowing down healing of tissues around the stent. Nanova, Inc. is developing a novel coating layer of high thrombo-resistance on the surface of metallic biomaterials of which coronary stents are made. An environmentally benign technology, low temperature plasma process is used to deposit an ultra-thin (nano-scale) but continuous layer of coating, sufficient to generate desired abrasion resistance and immobilize the bioactive functional groups created in the subsequent plasma surface treatment to prevent blood clots and restenosis, but thin enough to allow for stent expansion without cracking when delivered into patients. The knowledge gained in this innovative research project will also benefit research and development for improved biocompatibility in other implantable medical devices such as pacemakers, pulse generators, cardiac defibrillators and bio-sensors.

Public Health Relevance:
Nanova, Inc. is developing a novel coating process on coronary stents to prevent both restenosis of coronary arteries and late in-stent thrombosis (blood clots in stents) for treatment of coronary heart disease, which will benefit over one million of patients in the United States.

Thesaurus Terms:
Acute Myocardial Infarct;Acute Myocardial Infarction;American;Ammonia;Animals;Arterial Fatty Streak;Arterial Fatty Streaks;Arteries;Atheroma;Atheromatous;Atheromatous Degeneration;Atheromatous Plaque;Autopsy;Benign;Biocompatible Materials;Biological Testing;Biomaterials;Bizzozero's Corpuscle/Cell;Blood Clot;Blood Clotting;Blood Plasma;Blood Platelets;Blood Coagulation;Blood Leukocyte;Body Tissues;Cardiac;Cardiac Diseases;Cardiac Disorders;Cardiac Artery;Cardiac Infarction;Cell Adhesion;Cell Growth In Number;Cell Multiplication;Cell Proliferation;Cellular Adhesion;Cellular Proliferation;Cessation Of Life;Clinical;Clotting;Coagulation;Coagulation Process;Coronary;Coronary Disease;Coronary Artery;Coronary Heart Disease;Corrosion;Death;Deetjeen's Body;Defibrillators;Deposit;Deposition;Development;Development And Research;Drugs;Electric Shock Cardiac Stimulators;Endogenous Nitrate Vasodilator;Endothelium-Derived Nitric Oxide;Evaluation;Fibrin;Generations;Goals;Hayem's Elementary Corpuscle;Healed;Healing Abnormal;Healing Delayed;Healthcare;Heart Diseases;Heart Artery;Impaired Healing;Impaired Tissue Repair;Impaired Wound Healing;Inflammatory Response;Injury;Knowledge;Leiomyocyte;Leukocytes;Leukocytes Reticuloendothelial System;Marketing;Marrow Leukocyte;Marrow Platelet;Measurable;Mechanics;Medical Device;Medication;Metals;Mononitrogen Monoxide;Myocardial Infarct;Myocardial Infarction;Nitric Oxide;Nitrogen Monoxide;Nitrogen Protoxide;O Element;O2 Element;Oxygen;Pace Stimulators;Pacemakers;Patients;Pharmaceutic Preparations;Pharmaceutical Preparations;Phase;Physiologic Pulse;Plasma;Plasma Serum;Platelets;Platelets Reticuloendothelial System;Process;Pulse;R &D;R&D;R-Series Research Projects;R01 Mechanism;R01 Program;Recurrence;Recurrent;Reporting;Research Grants;Research Project Grants;Research Projects;Resistance;Reticuloendothelial System, Serum, Plasma;Risk;Safety;Si Element;Silicon;Smooth Muscle Cells;Smooth Muscle Myocytes;Smooth Muscle Tissue Cell;Solutions;Stainless Steel;Stents;Stimulators, Electrical, Cardiac, Shock;Stimulators, Electrical, Pace;Surface;Technology;Testing;Thrombocytes;Thrombosis;Tissues;United States;White Blood Cells;White Cell;Abnormal Tissue Repair;Abstracting;Adverse Consequence;Adverse Outcome;Atherosclerosis Plaque;Atherosclerotic Lesions;Atherosclerotic Plaque;Biocompatibility;Biological Material;Biomaterial Compatibility;Cardiac Infarct;Cold Temperature;Coronary Attack;Coronary Disorder;Coronary Infarct;Coronary Infarction;Delayed Wound Healing;Design;Designing;Developmental;Drug/Agent;Endothelial Cell Derived Relaxing Factor;Functional Group;Healing;Health Care;Heart Attack;Heart Disorder;Heart Infarct;Heart Infarction;Implantation;Improved;In Vivo;Innovate;Innovation;Innovative;Low Temperature;Mechanical;Monomer;Nano Meter Scale;Nano Meter Sized;Nano Scale;Nanometer Scale;Nanometer Sized;Nanoscale;Necropsy;Novel;Postmortem;Pre-Clinical Study;Pre-Clinical Trial;Preclinical Study;Preclinical Trial;Prevent;Preventing;Programs;Research And Development;Resistant;Restenosis;Sensor;Surface Coating;Thrombocyte/Platelet;Vulnerable Plaque;White Blood Cell;White Blood Corpuscle

Phase II

Contract Number: 4R44HL097485-02
Start Date: 8/21/2012    Completed: 7/31/2014
Phase II year
2012
(last award dollars: 2019)
Phase II Amount
$4,396,952

Improved long-term biocompatibility of coronary stents by plasma coating process Abstract Drug-eluting stents (DES) have been widely used to treat patients of cardiac disease due to their better ability to control restenosis than bare metal stents (BMS). However, a serious adverse outcome of late stent thrombosis in patients treated with DES has been reported, which leads to fatal heart attack and death even though it occurs at low rate. Thus, for safe and effective clinical use, a coronary stent needs to have better biocompatibility on its surface that will provide sufficient thrombo-resistance in addition to inhibiting cell proliferation thereby slowing down healing of tissues around the stent. Nanova, Inc. is developing a novel coating layer of high thrombo-resistance on the surface of metallic biomaterials of which coronary stents are made. An environmentally benign technology, low temperature plasma process is used to deposit an ultra-thin (nano-scale) but continuous layer of coating, sufficient to generate desired abrasion resistance and immobilize the bioactive functional groups created in the subsequent plasma surface treatment to prevent blood clots and restenosis, but thin enough to allow for stent expansion without cracking when delivered into patients. The knowledge gained in this innovative research project will also benefit research and development for improved biocompatibility in other implantable medical devices such as pacemakers, pulse generators, cardiac defibrillators and bio-sensors.