Second Heart Technology
High Flow, Low Profile
Wireless Power Option
Incorporating VibroCell vibrational technology designed to minimize risk of thrombosis
1. Temporary circulatory assist support pump(s) on tip of endovascular aortic catheter.
2. Removable chronic wireless powered implant circulatory assist pump within an aortic stent.
Designed to (proper randomized blinded placebo controlled clinical data is not available yet to support these intended uses yet):
• Reduce heart work load and improve perfusion.
• Improve renal function.
• Get acute decompensating heart failure patients back to normal hemodynamics.
• Support heart regeneration procedures.
• Help patients recover from cardiogenic shock.
• Reduce risks associated with percutaneous catheterization interventions (High Risk PCI).
• Help patients on amputation list to recover their limbs when used in combination with limb regeneration technologies such as bioelectric protein release and stem cell/growth factor composition injections (Limb Salvage).
- Super Easy Aorta Position Insertion
- Stable Over Time
- Provides hemodynamic support in minutes.
- Designed to minimize heart valve damage.
- Designed to minimize coronary re-perfusion injury.
- Low shear stress on blood. Minimizes hemolysis.
- Only circulatory assist pump with VibroCell vibrational energy designed to reduce thrombosis risk reduction.
- Wireless power option designed to reduce infection risk compared to external drive line systems.
- Wireless power designed to improve patient quality of life.
- Designed to reduce end diastolic pressure.
- Designed to reduce end diastolic volume.
- Designed to reduce oxygen demand of myocardium.
- *5 to 6 liters of flow per minute depending on aorta diameter and impeller speed.
Currently available circulatory assist devices face a number of significant limitations and drawbacks, including: Low flow rates that do not provide the full assistance patients need. Device-associated thrombosis that can block blood flow to vital organs, potentially resulting in a stroke, myocardial infarction, etc. High impeller speeds that can cause hemolysis and pump migration. Risks and complications associated with invasive implantation procedures that are required to deploy many circulatory assist devices. External equipment can decrease patient comfort and quality of life while limiting the range of activities a patient can participate in (swimming, etc.).
Second Heart’s technology is a minimally invasive solution that provides circulatory assistance to patients while overcoming many of the limitations of current options: Collapsible stent pump design allows for low profile catheter-based introduction for easy and secure placement in the aorta. Mechanical design provides high flow rates (over 7 liters per minute) while minimizing the risk of mechanical breakdown and reduces damage to blood cells (hemolysis). Thrombosis-resistant material, harmonic vibrational energy technology, and pulsatile flow all help to prevent blood clotting that can lead to stroke or myocardial infarction. Our patent-pending removable (and wirelessly powered) pulsating cuff stent is situated above the impeller pump providing a two pump “in-series” system. This wireless power source eliminates the need for percutaneous equipment that can serve as a site of infection and limit a patient’s quality of life.
Physiologically Accurate Mock Circulation Loop To Test Second Heart Assist Devices @ Cardiovacular Innovation Institute Louisville, KY
The target markets for Second Heart’s temporary circulatory assist pump include:
- Acute decompensated heart failure ― Of the estimated 1 million annual hospitalizations for decompensated heart failure, roughly 10% are complicated by reduced kidney function. Due to its placement, just above the renal arteries, patients with reduced kidney function stand to significantly benefit and represent 100,000 potential patients per year.
- High-risk PCI ― The estimated number of PCIs that occur each year in the U.S. ranges from 650,000 to 1.2 million (based on the specific source). Current estimates are that at least 10% of PCIs are considered high risk and could potentially benefit from a support device such as Second Heart’s. As a result, this market segment includes 65,000 to 120,000 patients.
Combined, these segments encompass 165,000 to 220,000 heart failure patients every year and result in an annual projected market of over $4.6 billion. A comparable that confirms the market potential is Abiomed, a manufacturer of catheter-based temporary circulatory assist devices indicated for high-risk PCI and cardiogenic shock. Over the past 5 years they have seen 30% annual growth with Impella sales generating $310 million of revenue in 2016. Even with less than 10% of their projected market, Abiomed has achieved a market capitalization of over $5 billion.
The market for Second Heart’s chronic aortic implant will be heart failure patients who require long-term circulatory support. Since many of these patients are unable to receive a heart transplant (due to organ shortage, contraindications, etc.), they currently rely on cardiac assist devices such as ventricular assist devices (VADs). The LVAD market is expected to grow at 7.9% annually over the next 5 years to reach a total revenue of roughly $900 million in 2021.
Investigational Use Only: Not Available for Sale. Product not yet tested to support any clinical claims. Early stage development.
WARNING: Early stage development. NOT AVAILABLE FOR SALE. INVESTIGATIONAL USE ONLY WITH PROPER REGULATORY CLEARANCES ONLY. Animal use only at this time. Prospective, randomized, multi-center, double blinded, placebo controlled clinical evaluations of Second Heart circulatory assist pumps to assess safety in supporting cardiovascular haemodynamics in patients have yet to be completed. No clinical claims for these devices are supported at this time.