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U.S. Artificial Heart Valve Markets

Published by: Frost & Sullivan

Published: Nov. 30, 2006


Table of Contents



1. Executive Summary

        1. Executive Summary

                  1. Executive Summary



2. U.S. Artificial Heart Valves Market

        1. Market Overview

                  1. Overview

                  2. Scope and Segmentation

        2. Market Trends

                  1. Market Drivers

                  a. Increased Device Durability Spurs Confidence in Device Usage

                  b. Lack of Effective Pharmaceutical or other Non-invasive Treatment for Heart Valve Disease Heightens Demand for Interventional Devices

                  c. Advances in Polymer Technology Augment Biomimetic Device Performance

                  d. Increased Screening and Diagnosis Expand Patient Population

                  2. Market Restraints

                  a. Saturated Patient Population Limits Market Potential for Growth

                  b. Price Stagnation Inhibits Market

        3. Challenges and Strategies

                  1. Industry Challenges

                  2. Strategies

        4. Market Forecasts and Analysis

                  1. Market Engineering Measurements

                  2. Total Revenue Forecasts

                  3. Total Heart Valve Replacement Procedures

                  4. Procedural Volume by Valve Type

        5. Competitive Analysis

                  1. Competitive Structure

                  2. Competitive Factors

                  3. Distribution Structure

                  4. Key End-user Group

                  5. Market Share Analysis

        6. Technology and Market Trends

                  1. Emerging Technologies

                  2. Mergers and Acquisitions

                  3. Start-up Market Activity

                  4. Reimbursement Trends

                  5. Regulatory Trends



3. Tissue Valve Replacement Market

        1. Market Forecast and Analysis

                  1. Market Overview

                  2. Market Engineering Measurements

                  3. Revenue Forecasts

                  4. Procedure Forecasts

        2. Competitive Analysis

                  1. Market Share Analysis

                  2. Product Chart



4. Mechanical Valve Replacement Market

        1. Market Forecast and Analysis

                  1. Market Overview

                  2. Market Engineering Measurements

                  3. Revenue Forecasts

                  4. Procedure Forecasts

        2. Competitive Analysis

                  1. Market Share Analysis

                  2. Product Chart



5. Heart Valve Repair Products

        1. Market Forecast and Analysis

                  1. Market Overview

                  2. Market Engineering Measurements

                  3. Revenue Forecasts

        2. Competitive Analysis

                  1. Market Share Analysis

                  2. Product Chart



6. Decision Support Databases

        1. Decision Support Databases

                  1. Population 65 and above

                  2. Obesity Rates

                  3. Hospitals

                  4. Cardiovascular Mortality

                  5. Cardiologists

                  6. Cerebrovascular Mortality

                  7. Cerbrovasular Hospital Discharge


List of Figures


Chapter 2

  • Artificial Heart Valve Market: Market Drivers Ranked in Order of Impact (U.S.), 2006-2012
  • Artificial Heart Valve Market: Market Restraints Ranked in Order of Impact (U.S.), 2006-2012
  • Artificial Heart Valve Market: Challenges and Corresponding Strategic Recommendations (U.S.), 2006-2012
  • Artificial Heart Valve Market: Revenue Forecasts (U.S.), 2002-2012
  • Artificial Heart Valve Market: Procedure Forecasts (U.S.), 2002-2012
  • Artificial Heart Valve Market: Replacement Forecasts by Anatomical Location (U.S.), 2004-2006
  • Artificial Heart Valve Market: Competitive Structure (U.S.), 2005
  • Artificial Heart Valve Market: Market Participant by Area (U.S.), 2005
  • Artificial Heart Valve Market: Venture Landscape (U.S.), 2005

Chapter 3

  • Tissue Valve Replacement Market: Revenue Forecasts (U.S.), 2002-2012
  • Tissue Valve Replacement Market: Procedure Forecasts (U.S.), 2002-2012
  • Tissue Valve Replacement Market: Average Selling Price Forecast (U.S.), 2002-2012
  • Tissue Valve Replacement Market: Market Share Trends of Major Market Participants (U.S.), 2005
  • Tissue Valve Replacement Market: Product Profile (U.S.), 2005

Chapter 4

  • Mechanical Valve Replacement Market: Revenue Forecasts (U.S.), 2002-2012
  • Mechanical Valve Replacement Market: Procedure Forecasts (U.S.), 2002-2012
  • Mechanical Valve Replacement Market: Average Selling Price Forecast (U.S.), 2002-2012
  • Mechanical Valve Replacement Market: Market Share Trends of Major Market Participants (U.S.), 2005
  • Mechanical Valve Replacement Market: Product Profile (U.S.), 2005

Chapter 5

  • Valve Repair Market: Revenue Forecasts (U.S.), 2002-2012
  • Valve Repair Market: Market Share Trends of Major Market Participants (U.S.), 2005
  • Valve Repair Market: Product Profile (U.S.), 2005

Abstract

Research Overview

The Frost & Sullivan research service titled U.S. Artificial Heart Valve Markets provides an overview of the trends and technologies that have shaped market revenues, market share, and implantation rates in the individual segments of the market. In this research service, Frost & Sullivan's expert analysts thoroughly examine the following markets: tissue replacement valves, mechanical replacement valves, and heart valve repair products.

Market Sectors

Expert Frost & Sullivan analysts thoroughly examine the following market sectors in this research:
  • Mechanical Heart Valves
  • Bioprosthetic Valves
  • Repair Products
Technologies

The following technologies are covered in this research service:
  • Mechanical Valves: These are made from materials such as stainless steel, silicone, teflon, and polycarbons. Given their durability, mechanical valves are primarily used for young patients, and to replace the mitral valve, due its high pressure gradient. Unlike tissue valves, once implanted they never wear down, and rarely ever have to be replaced.
  • Bioprosthetic Valves: Bioprosthetic valves are harvested tissue valves from either human or animal donors. Human bioprosthetic valves are either obtained from cadavers (allograft), or from one's own body (autograft).
  • Heart Valve Repair Products: These devices include percutaneous tools to access heart valves minimally invasively, annuloplasty rings to tighten and structure valves, and other tissue modeling instruments.
Market Overview

Increased Device Durability Spurring Confidence in New Bioprosthetic Replacement Heart Valves

The cardiovascular system is one of the most complicated systems in the human body. It requires the coordination of a number of muscles, valves, and nerves to ensure consistent and constant blood flow. Any disruption or malfunction in the process, could lead to death within minutes.

A key mechanism in that process is the functionality of the small tissue valves located in each of the four chambers of the heart. These small tissue flaps serve as one way gates to control flow of blood, and ensure no reverse leakage. When these tissue flaps become diseased, they can create major problems for cardiovascular function. If the diseased valve is weakened, creating a gap, there is a regurgitation of flow. On the opposite end of the spectrum, if the valve undergoes stenosis, the narrowed valve opening forces the heart to exert more force, and thereby stress to maintain blood flow. Most of these conditions develop over time, and when diagnosed require immediate attention. Due to a lack of significant pharmaceutical therapies that can reverse valvular disease, primary intervention is the gold standard for care.

When a defect is detected, a specialist must make the decision if the valve can be repaired, or it needs to be replaced. Heart valve repair with annuloplasty involves the stitching of a ring at the base of the valve in order to help it maintain a level of tightness. If repair is too risky or the valve is beyond repair, the valve is replaced outright with an artificial valve.

Artificial heart replacement valves have been in existence since the 1950’s. While there have been significant upgrades in the materials used and methodology of implantation for these devices, currently used devices are essentially analogous to the first generation of devices developed fifty years ago. Surgeons must weigh the options between selecting a mechanical tissue valve, or one made of animal tissue. The issues of selecting one over the other are the same trade off that has existed since their inception. Mechanical valves are more durable, while tissue valves are more biocompatible.

As the societal demographic shifts towards an older and more obese population, there is a heightened demand for advanced heart valve therapy products.

Market Dedicating Focus to Design of Percutaneous Products

Endovascular surgeries are becoming the preferred approach for treating cardiovascular diseases. Being able to insert a catheter in a peripheral blood vessel, and perform a surgery anywhere in the body has immense appeal to surgeons. They have become well versed in the techniques and tools involved for minimally invasive procedures, and see an immense benefit over open cavity approaches. Therefore, with respect to replacement heart valve implantation and heart valve repair, clinicians are looking to manufacturers that can provide them the most advanced minimally invasive solutions. Since each device has its own specifics for operation, once a provider trains himself on a certain product it becomes increasingly more difficult to convert them to a competitor’s device. Therefore, it is important that manufacturers keep pace with competitors and introduce the latest in percutaneous products, or else sacrifice future sales as a late arriver.

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