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Transcatheter Heart Valve Therapies

We have in-depth knowledge and hands on experience in the Transcatheter Heart Valves therapies

  1. Transcatheter Aortic Valve Replacement (TAVR)
  2. Transcatheter Mitral Valve Replacement (TMVR)
  3. Tricuspid Valve
  4. Pulmonic Valve

We have been working in the field of Transcatheter Heart Valves Industry starting with first TAVR ­ CoreValve and Ventor Technologies (Engager). We have worked closely hand in hand with our clients on overcoming many complex issues and successfully guided them. We address the needs of companies of all sizes from startups to global medical device companies.

We are pioneers in helping many TAVR & TMVR companies. We take pride in consulting to the first TMVR Company to successfully complete its FIH by providing various below mentioned consulting services. We are uniquely placed to consult and make companies in the TAVR, TMVR and Pulmonary/Tricuspid space succeed whether they are start-ups or global device companies.

  • Successfully completed many engagements in Transcatheter Heart Valves
  • Responsive and hands-on experience leading to success at the first go
  • In-depth domain knowledge of Transcatheter Heart Valves
  • Always work with client’s goal in mind

 

We provide the following services:

CONTRACT MANUFACTURING ORGANIZATION (CMO)

END to END Sourcing the tissue from slaughter house to delivering the finished valve for FIH or clinical trail

  • Procure Tissue (Bovine or Porcine)
  • Tissue Fixation
  • Produce stent as per client IP
  • Sew valve to stent as per client IP
  • Produce final valve ready of animal testing, FIH or clinical trails

Regulatory

  • Strategy – obtaining approvals for First in Human (FIH)
  • Strategy – obtaining CE marking (regular tract and fast track)
  • Accelerated FDA-IDE approvals PMA applications and approvals
  • Design Dossier for CE approvals
  • Other geographies such as Japan, China, Australia, South America, Korea etc.

Tissue Fixation

  • Procure tissue (bovine or porcine) and set up methodologies to cross-link and preserve the tissue
  • Perform qualification / validation of the tissue cross- linking process
  • Set up manufacturing facility for the tissue fixation
  • Train clients to independently prepare tissue for their manufacturing

Set up wet chemistry lab to prepare solutions

  • Design and develop the solutions required for TAVR / TMVR manufacturing. E.g., fixation solution, storage solution, sterilant etc.
  • Set up chemistry lab with chemicals and equipment needed
  • Perform qualification validation for solution preparation
  • Train clients to independently prepare solutions for their manufacturing

Anti-calcification Treatment

  • End to end design, develop, and implement anti-calcification treatment

Biocompatibility Testing

  • Design and develop testing strategy for FIH, CE marking, FDA IDE / PMA
  • Perform necessary testing as per ISO 10993 and FDA guidance documents

Large Animal Testing

  • Functional / feasibility testing in large animals such as sheep / pig (acute)
  • Chronic animal studies as per FDA guidance documents and ISO 5840
  • In-vivo thrombogenicity test

Viral In-activation

  • Perform viral inactivation studies
  • Write protocol for final reports

TSE/BSE

  • Perform TSE / BSE clearance studies Protocol – final reports
  • Tissue risk assessment / mitigations

Transcatheter valve crisis management

  • Manufacturing trouble shooting
  • Prepare response to regulatory findings
  • Nonconformances / CAPA
  • Resolve non-compliant testing, device structural issues, sterility issues, and provide support to resume FIH and clinical trials
  • Other related unforeseen challenges