Milestones
WorldHeart's Novacor® LVAS milestones have helped return heart patients to their homes, hobbies, jobs and families:
2006:
- In early March, the first human implant of the Levacor VAD was performed by the surgical team at St. Luke's Hospital, Thessaloniki, Greece. The successful implant marks the start of the feasibility clinical trial.
- The next-generation pulsatile VAD, the Novacor II, entered key phase of animal testing with the first chronic animal implant.
2005:
- CMS establshed outpatient billing codes for the replacement of LVAD supplies and equipment which furthers reimbursement to centers implanting VADs.
- WorldHeart acquires assets of MedQuest Products Inc., obtaining a magnetically levitated rotary blood pump. The acquisition structures WorldHeart as the only company to currently be developing a full product platform of ventricular assist devices: pulsatile, next-generation pulsatile and rotary.
- First patient in the United States to be weaned successfully from the Novacor® LVAS: 45-year old woman suffering from viral cardiomyopathy with severe biventricular failure and cardiogenic shock became the first patient in the United States to be weaned from a ventricular assist device. Previously, weaning of patients has only been conducted in Europe.
2004:
- The Novacor® LVAS which was previously reimbursed under DRG 525 (diagnosis - related group), is now reimbursed under DRG 103, the highest paying DRG that covers heart transplantation procedures. This represents an increase in reimbursement to centers implanting VADs by approximately 30-40%.
- First implant in the Novacor® LVAS RELIANT (Randomized Evaluation of Novacor® LVAS In A Non-Transplant Population) Destination Therapy Trial: 51-year-old man suffering from severe heart failure became the first patient to receive an implanted left ventricular assist system (LVAS) in the RELIANT Trial for Destination Therapy. Dr. Richard N. Pierson III at the University of Maryland Medical Center performed the procedure in this landmark trial.
- Novacor® LVAS recipient continues to hold world record for continuous support on a single device, over 4 years.
- The U.S. Food and Drug Administration (FDA) grants unconditional approval to WorldHeart to proceed with the RELIANT (Randomized Evaluation of Novacor® LVAS In A Non-Transplant Population) Destination Therapy Trial for enrollment of up to 390 patients in up to 40 United States centers.
- The U.S. Food and Drug Administration (FDA) approves WorldHeart's Pre-market Approval Supplement submission to incorporate several engineering enhancements to the implanted and external components of its Novacor® LVAS.
- In Germany, the 1,500th patient is implanted with Novacor® LVAS.
- Novacor® LVAS patient reaches 6th year of support - a historic milestone for WorldHeart and the LVAD industry as a whole.
2003:
- Health Canada approves engineering enhancements to Novacor® LVAS.
- WorldHeart announces the Novacor® LVAS Pivotal Trial for Destination Therapy in approximately 40 centers in the United States, in which Novacor® LVAS is compared to HeartMate® XVE LVAS in use as Destination Therapy for patients suffering from irreversible left ventricular failure who are not transplant candidates.
2002:
- Novacor® LVAS becomes the first implanted heart assist device to support a single patient for longer than five years.
- In Japan, the 101st patient to reach more than one year of support with the LVAS. This same year, the Japanese Ministry of Health, Education and Welfare (MHLW) grants an import license for the Novacor® LVAS.
- Introduction of Novacor® LVAS product engineering enhancements (quieter pump, lighter & smaller batteries).
2000:
- WorldHeart acquires Novacor, an Oakland, California, ventricular assist device operation from Edwards Lifesciences LLC of Irvine, California.
- First Novacor® LVAS recipient for Destination Therapy (Feasibility study - INTrEPRID).
1998:
- Novacor® LVAS receives FDA approval for a Bridge-to-Transplant indication for use in U.S.A.
1996:
- WorldHeart is established and acquires exclusive worldwide rights to the "EVAD" artificial heart and related technologies developed by CVD at the University of Ottawa Heart Institute. EVAD provides the basis for WorldHeart's technologies.
1994:
- Novacor® LVAS receives CE mark in Europe, without restriction as to the indication for use.
1993:
- Novacor® LVAS wearable configuration introduced in Europe.
1990:
- First LVAS patient discharged home with a Novacor® LVAS.
1989
- Novacor® LVAS, first and only LVAS, to meet and exceed the U.S. National Institutes of Health (NIH) multi-year device readiness test protocol.
1984:
- First human implant and successful Bridge-to-Transplant is a Novacor® LVAS.
