The Company, based in Menlo Park, CA, has developed a novel transcatheter implant called the Parachute® Ventricular Partitioning Device (Parachute®). The Parachute® intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.
Patient Unmet Needs
Heart failure (HF) imposes one of the highest disease burdens of any medical condition in the world with an estimated 23 million patients experiencing HF. Heart failure is also one of the most resource-intensive conditions with direct and indirect costs in the United States estimated at $39.2 billion in 2010. The overall mortality and readmission rates for heart failure continue to remain unacceptably high even with the array of available drugs, devices, and/or surgical techniques.
There are a number of treatment options available to minimize symptoms and somewhat slow disease progression. The combination of lifestyle changes and drug therapy—the foundation of almost all HF treatment regimens—can improve both survival rates and quality of life and is most often initiated in NYHA Class I and Class II patients. Each class of heart failure may warrant a different combination of medications. If drug therapy does not adequately enhance LV function, patients with advanced heart failure may become candidates for other interventions, including surgery and implantable devices.
Approximately 25% of patients with advanced (ischemic) HF have ventricular dysynchrony resulting in a reduction of cardiac output. Patients with advanced HF and ventricular dysynchrony are most likely to benefit from the simultaneous pacing of both right and left ventricles, or cardiac resynchronization therapy (CRT). Some CRT devices also provide defibrillation to protect against sudden cardiac death resulting from arrhythmias. In addition, some Implantable Cardiac Defibrillators (ICDs) have a CRT “capacity” and can be used in such patients to provide HF therapy combined with prophylactic treatment of ventricular fibrillation or sudden death.
In addition to medical therapy and CRT, some patients may also be eligible for surgical therapy of heart failure, with 4 possibilities:
- Coronary artery bypass surgery to supply more blood flow in ischemic zones when the coronary arterial network lends itself to bypass surgery.
- Mitral surgery, by repair or replacement, can benefit patients with significant mitral regurgitation due to LV dilatation.
- Left Ventricular Assist Devices (LVAD’s) – The LVAD improves cardiac output by pumping blood in parallel with the weakened heart chamber. The new portable LVAD units enable some patients to resume some activities after discharge from the hospital. Recently, LVAD’s were approved for so called “destination therapy” as an alternative to heart transplantation in those patients not eligible for a heart transplant procedure.
- Transplant Surgery –For a small percentage of patients with HF, heart transplantation is employed as a lifesaving intervention in patients meeting specific criteria and who are in end-stage HF. These are patients with no other options who meet all of the criteria for transplant surgery. Less than 2,000 heart transplants are performed each year in the US, representing less than 1% of all patients with HF. Other surgeries may be considered if there is comorbidity amenable to concomitant surgical therapy such as Coronary Artery Bypass Grafting (CABG) or mitral valve repair or replacement.
While the above therapies may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device.