NCT01678144 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Jensen H, Simpanen J, Smerup M, Bjerre M, Bramsen M, Werkkala K, Vainikka T, Hasenkam JM, Wierup P
Medtentia double helix mitral annuloplasty system evaluated in a porcine experimental model. Innovations (Phila). 2010 Mar;5(2):114-7. doi: 10.1097/IMI.0b013e3181d84316.
Konerding MA, Simpanen J, Ihlberg L, Aittomäki J, Werkkala K, Delventhal V, Ackermann M
Comparison of the novel Medtentia double helix mitral annuloplasty system with the Carpentier-Edwards Physio annuloplasty ring: morphological and functional long-term outcome in a mitral valve insufficiency sheep model. J Cardiothorac Surg. 2013 Apr 8;8:70. doi: 10.1186/1749-8090-8-70.

Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery

Clinical trial NCT01678144 - References