Mechanical Heart Valves Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

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Published: June 20, 2022 Report Code: GDME1383EPD-ST

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Mechanical heart valves are generally made of non–physiological materials with a mobile occluder, which is made of rigid materials. This segment comprises Mechanical Sutured Mitral Valve Replacements and Mechanical Sutured Aortic Valve Replacements. The Mechanical Heart Valves Pipeline products report provides details of major pipeline products which include product description, licensing and collaboration details, and other developmental activities including pipeline territories, regulatory paths, and estimated approval dates.

What is the territory outlook of the mechanical heart valves pipeline products market?

The US, India, China, and Europe have products in the pipeline. As of June 2022, the US has the highest number of products in the pipeline out of them all.

Mechanical heart valves pipeline products market, by territory

Mechanical heart valves pipeline products market, by territory

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What are the key segments in the mechanical heart valves pipeline products market?

The key segment in the mechanical heart valves pipeline products market is mechanical sutured mitral valve replacements.

What are the regulatory paths for the mechanical heart valves pipeline products market?

The regulatory path followed by the Mechanical heart valves pipeline products are PMA, ICAC, NMPA, and CE. The majority of products follow the PMA pathway to enter the market.

Mechanical heart valves pipeline products market, by regulatory path

Mechanical heart valves pipeline products market, by regulatory path

For more regulatory path insights, download a free report sample

What are the key companies in the mechanical heart valves pipeline products market?

Some of the key companies in the mechanical heart valves market are Artivion Inc, Autus Valve Technologies Inc, Innovator Lab Consultants India Pvt Ltd, Innovia LLC, Meril Life Sciences Pvt Ltd, On-X Life Technologies Inc, Shanghai Aoliu Medical Technology Co Ltd, TTK Healthcare Ltd, and University of Pittsburgh Medical Center. 

Artivion Inc

Artivion Inc (Artivion) is a medical device company that manufactures and distributes biosurgical devices and implantable human tissues for cardiac and vascular surgical procedures for the treatment of aortic disease. The company’s portfolio enlists preserved human cardiac allografts, vascular allografts, surgical adhesives and sealants, heart valves, bovine pericardium, mitral chordal repair products, photofix products, and Jotec products. Artivion is headquartered in Atlanta, Georgia, the US.

Autus Valve Technologies Inc

Autus Valve Technologies Inc (AVT) focuses on development of prosthetic heart valves. AVT is headquartered in Needham, Massachusetts, the US.

Meril Life Sciences Pvt Ltd

Meril Life Sciences Pvt Ltd (Meril) designs, develops, and manufactures medical devices. The company offers vascular intervention devices such as stents, scaffolds, catheters, inflation, and vascular closure devices and orthopedic implants such as knee and hip replacement systems and instrument sets. Its diagnostic product range includes analyzers, reagents for clinical biochemistry, hematology, immunology, rapids, critical care, diabetes management, coagulation and lab consumables. Meril is headquartered in Vapi, Gujarat, India.

To know more about leading companies in the mechanical heart valves pipeline products market, download a free report sample

Market report scope

Key territories The US, India, China, and Europe
Key segment Mechanical Sutured Mitral Valve Replacements
Key regulatory paths PMA, ICAC, NMPA, and CE
Key companies Artivion Inc, Autus Valve Technologies Inc, Innovator Lab Consultants India Pvt Ltd, Innovia LLC, Meril Life Sciences Pvt Ltd, On-X Life Technologies Inc, Shanghai Aoliu Medical Technology Co Ltd, TTK Healthcare Ltd, and University of Pittsburgh Medical Center

This report provides:

  • Extensive coverage of the Mechanical heart valves market under development.
  • Details of major pipeline products which include product description, licensing and collaboration details, and other developmental activities.
  • The major players involved in the development of Mechanical heart valves and list all their pipeline projects.
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage.
  • Key clinical trial data of ongoing trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.

  • Identify emerging players with potentially strong product portfolio and create effective counterstrategies to gain a competitive advantage.

  • Identify and understand important and diverse types of Mechanical heart valves under development.

  • Develop market-entry and market expansion strategies.

  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.

  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Artivion Inc
Autus Valve Technologies Inc
Innovator Lab Consultants India Pvt Ltd
Innovia LLC
Meril Life Sciences Pvt Ltd
On-X Life Technologies Inc
Shanghai Aoliu Medical Technology Co Ltd
TTK Healthcare Ltd
University of Pittsburgh Medical Center

Table of Contents

1 Table of Contents 3

|1.1 List of Tables 4

|1.2 List of Figures 6

2 Introduction 7

2.1 Mechanical Heart Valves Overview 7

3 Products under Development 8

3.1 Mechanical Heart Valves – Pipeline Products by Stage of Development 8

3.2 Mechanical Heart Valves – Pipeline Products by Segment 9

3.3 Mechanical Heart Valves – Pipeline Products by Territory 10

3.4 Mechanical Heart Valves – Pipeline Products by Regulatory Path 11

3.5 Mechanical Heart Valves – Pipeline Products by Estimated Approval Date 12

3.6 Mechanical Heart Valves – Ongoing Clinical Trials 13

4 Mechanical Heart Valves – Pipeline Products under Development by Companies 14

4.1 Mechanical Heart Valves Companies – Pipeline Products by Stage of Development 14

4.2 Mechanical Heart Valves – Pipeline Products by Stage of Development 15

5 Mechanical Heart Valves Companies and Product Overview 16

5.1 Artivion Inc Company Overview 16

5.1.1 Artivion Inc Pipeline Products & Ongoing Clinical Trials Overview 16

5.2 Autus Valve Technologies Inc Company Overview 20

5.2.1 Autus Valve Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.3 Innovator Lab Consultants India Pvt Ltd Company Overview 23

5.3.1 Innovator Lab Consultants India Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

5.4 Innovia LLC Company Overview 24

5.4.1 Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 24

5.5 Meril Life Sciences Pvt Ltd Company Overview 26

5.5.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

5.6 On-X Life Technologies Inc Company Overview 30

5.6.1 On-X Life Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.7 Shanghai Aoliu Medical Technology Co Ltd Company Overview 31

5.7.1 Shanghai Aoliu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

5.8 TTK Healthcare Ltd Company Overview 32

5.8.1 TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.9 University of Pittsburgh Medical Center Company Overview 33

5.9.1 University of Pittsburgh Medical Center Pipeline Products & Ongoing Clinical Trials Overview 33

6 Mechanical Heart Valves- Recent Developments 34

6.1 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 34

6.2 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 34

6.3 Apr 01, 2022: Japan Lifeline Announces a New Appointment of Operating Officer 34

6.4 Jan 28, 2022: Japan Lifeline Co. Announces Consolidated Financial Results for the Nine months Ended December 31, 2021 34

6.5 Jan 04, 2022: Medtronic Chairman and CEO Geoff Martha to speak at J.P. Morgan healthcare conference 35

6.6 Nov 01, 2021: Japan Lifeline Announces FY3/2022 2Q Financial Results 35

6.7 Aug 04, 2021: Japan Lifeline Announces FY3/2022 1Q Financial Results 36

6.8 Jul 14, 2021: Inappropriate anticoagulation of patients with a mechanical heart valve 36

6.9 Jun 25, 2021: Japan Lifeline Notice of Resolution of the 41st Annual General Meeting of Shareholders 37

7 Appendix 39

7.1 Methodology 39

7.2 About GlobalData 41

7.3 Contact Us 42

7.4 Disclaimer 42

Table

Mechanical Heart Valves – Pipeline Products by Stage of Development 8

Mechanical Heart Valves – Pipeline Products by Segment 9

Mechanical Heart Valves – Pipeline Products by Territory 10

Mechanical Heart Valves – Pipeline Products by Regulatory Path 11

Mechanical Heart Valves – Pipeline Products by Estimated Approval Date 12

Mechanical Heart Valves – Ongoing Clinical Trials 13

Mechanical Heart Valves Companies – Pipeline Products by Stage of Development 14

Mechanical Heart Valves – Pipeline Products by Stage of Development 15

Artivion Inc Pipeline Products & Ongoing Clinical Trials Overview 16

On-X Mechanical Aortic Valve – ELIQUIS – Product Status 16

On-X Mechanical Aortic Valve – ELIQUIS – Product Description 17

On-X Mitral Heart Valve – Product Status 17

On-X Mitral Heart Valve – Product Description 17

Artivion Inc – Ongoing Clinical Trials Overview 18

On-X Mechanical Aortic Valve – ELIQUIS – A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants with an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban 19

Autus Valve Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Autus Size-Adaptable Valve – Product Status 20

Autus Size-Adaptable Valve – Product Description 20

Autus Valve Technologies Inc – Ongoing Clinical Trials Overview 21

Autus Size-Adaptable Valve – Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Early Feasibility Study 22

Innovator Lab Consultants India Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Mechanical Heart Valve 2.0 – Product Status 23

Mechanical Heart Valve 2.0 – Product Description 23

Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 24

Minimally Invasive Synthetic Tri – Leaflet Heart Valve – Product Status 24

Minimally Invasive Synthetic Tri – Leaflet Heart Valve – Product Description 24

Percutaneous Synthetic Tri – Leaflet Heart Valve – Product Status 25

Percutaneous Synthetic Tri – Leaflet Heart Valve – Product Description 25

Sutured In Synthetic Tri – Leaflet Heart Valve – Product Status 25

Sutured In Synthetic Tri – Leaflet Heart Valve – Product Description 25

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

Miltonia-UNO – Product Status 26

Miltonia-UNO – Product Description 26

MYVAL 2 – Product Status 27

MYVAL 2 – Product Description 27

MyVal Genesis – Product Status 27

MyVal Genesis – Product Description 27

MYVAL HEXA – Product Status 28

MYVAL HEXA – Product Description 28

MyVal Integra – Product Status 28

MyVal Integra – Product Description 28

Myval Rondevu – Product Status 29

Myval Rondevu – Product Description 29

On-X Life Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 30

On-X Mitral Valve-Low INR – Product Status 30

On-X Mitral Valve-Low INR – Product Description 30

Shanghai Aoliu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

Congenital Heart Valve Device – Product Status 31

Congenital Heart Valve Device – Product Description 31

TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Second Generation TTK-Chitra Heart valve – Product Status 32

Second Generation TTK-Chitra Heart valve – Product Description 32

University of Pittsburgh Medical Center Pipeline Products & Ongoing Clinical Trials Overview 33

Infant Metallic Valve – Product Status 33

Infant Metallic Valve – Product Description 33

Glossary 41

Figures

Mechanical Heart Valves – Pipeline Products by Stage of Development 8

Mechanical Heart Valves – Pipeline Products by Segment 9

Mechanical Heart Valves – Pipeline Products by Territory 10

Mechanical Heart Valves – Pipeline Products by Regulatory Path 11

Mechanical Heart Valves – Pipeline Products by Estimated Approval Date 12

Mechanical Heart Valves – Ongoing Clinical Trials 13

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