Business Wire11.10.16
NeoChord Inc. has surpassed the 500 patient treatment threshold for its DS1000 Artificial Chordae Delivery System.
With traditional open mitral repair procedures, the heart is stopped, and the patient is placed on cardiopulmonary bypass. With the NeoChord System, the mitral valve is repaired while the heart is beating, and a real-time assessment of the correction of mitral regurgitation is performed.
“Achievement of a 500+ patient treatment milestone affirms the adoption of this new procedure in Europe. The excellent two-year outcomes from the University of Padua may be an early confirmatory signal for the long term durability of our procedure and confirms the promise that this technology holds for patients suffering from degenerative mitral valve disease. We believe these impressive results will also be observed in the U.S. pivotal trial, which will commence this year,” said David Chung, CEO and president of NeoChord.
New data from the University of Padua demonstrated that patients had improved ventricular function, no increase in mitral annular dimension, and no recurrence or worsening of mitral regurgitation at up to two years after treatment with the NeoChord DS1000 System and was presented at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Barcelona.
“We are very pleased with the mid-term clinical outcomes observed in our series of patients with prolapsed and flail leaflets,” stated Professor Gino Gerosa M.D., Ph.D., chief of cardiac surgery, Department of Cardiac, Thoracic, and Vascular Sciences at the University of Padua in Italy. “The one-year results in our series has been previously reported, so it is extremely promising to observe that these results have been sustained in our patients out to two years. While we will continue to study these patents, these data suggest that concomitant annuloplasty may not be mandatory in the treatment of degenerative mitral valve regurgitation.”
Dr. Andrea Colli, M.D., Ph.D., FECTS, Department of Cardiac, Thoracic, and Vascular Sciences at the University of Padua, reported on the two-year outcomes of 127 patients that received echo-guided transapical, off-pump mitral valve repair with artificial chordae implantation with the NeoChord Artificial Chordae Delivery System, Model DS1000. “In our series, we observed improvement in left ventricular function, (p=0.001), and no increase in mitral annular dimension, (p=0.862) between the follow-up periods of discharge and two-years,” said Colli. “These data are remarkable because they are consistent with results that have been reported and are expected in open mitral repair procedures.”
Based in St. Louis Park, Minn., NeoChord is a privately held developer of minimally invasive repair technologies for degenerative mitral regurgitation (DMR). DMR is a progressive disease that can result in atrial fibrillation, congestive heart failure, and death when left untreated. NeoChord received CE market clearance in December 2012 for the DS1000 System to treat DMR without the use of cardiopulmonary bypass. NeoChord received IDE approval from the U.S. Food and Drug Administration to begin the U.S. pivotal trial in May 2016.
With traditional open mitral repair procedures, the heart is stopped, and the patient is placed on cardiopulmonary bypass. With the NeoChord System, the mitral valve is repaired while the heart is beating, and a real-time assessment of the correction of mitral regurgitation is performed.
“Achievement of a 500+ patient treatment milestone affirms the adoption of this new procedure in Europe. The excellent two-year outcomes from the University of Padua may be an early confirmatory signal for the long term durability of our procedure and confirms the promise that this technology holds for patients suffering from degenerative mitral valve disease. We believe these impressive results will also be observed in the U.S. pivotal trial, which will commence this year,” said David Chung, CEO and president of NeoChord.
New data from the University of Padua demonstrated that patients had improved ventricular function, no increase in mitral annular dimension, and no recurrence or worsening of mitral regurgitation at up to two years after treatment with the NeoChord DS1000 System and was presented at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Barcelona.
“We are very pleased with the mid-term clinical outcomes observed in our series of patients with prolapsed and flail leaflets,” stated Professor Gino Gerosa M.D., Ph.D., chief of cardiac surgery, Department of Cardiac, Thoracic, and Vascular Sciences at the University of Padua in Italy. “The one-year results in our series has been previously reported, so it is extremely promising to observe that these results have been sustained in our patients out to two years. While we will continue to study these patents, these data suggest that concomitant annuloplasty may not be mandatory in the treatment of degenerative mitral valve regurgitation.”
Dr. Andrea Colli, M.D., Ph.D., FECTS, Department of Cardiac, Thoracic, and Vascular Sciences at the University of Padua, reported on the two-year outcomes of 127 patients that received echo-guided transapical, off-pump mitral valve repair with artificial chordae implantation with the NeoChord Artificial Chordae Delivery System, Model DS1000. “In our series, we observed improvement in left ventricular function, (p=0.001), and no increase in mitral annular dimension, (p=0.862) between the follow-up periods of discharge and two-years,” said Colli. “These data are remarkable because they are consistent with results that have been reported and are expected in open mitral repair procedures.”
Based in St. Louis Park, Minn., NeoChord is a privately held developer of minimally invasive repair technologies for degenerative mitral regurgitation (DMR). DMR is a progressive disease that can result in atrial fibrillation, congestive heart failure, and death when left untreated. NeoChord received CE market clearance in December 2012 for the DS1000 System to treat DMR without the use of cardiopulmonary bypass. NeoChord received IDE approval from the U.S. Food and Drug Administration to begin the U.S. pivotal trial in May 2016.
