Peripheral Arterial & Venous Disease
Stroke (M1 – M4 access)
Wound Care
Coronary Disease
Targeted Cancer Therapy
Today’s medical devices cannot access smaller vascular beds.
Recanalization in Lower Limb Occlusions
Peripheral artery disease is a narrowing of the peripheral arteries serving the legs, stomach, arms and head. Peripheral Artery Disease (PAD) affects 12 million people in the United States every year.
Atherosclerosis (plaque buildup) in the peripheral arteries is the most common cause of PAD often leading to a chronic total occlusion (CTO) over time. CTO narrowing occurs more gradually than stroke, however these are no less life threatening and certainly difficult to treat.
CTO cases have been plagued with difficulties including:
- Inability to cross the lesion
- Increased use of resources (costs)
- 2-3 times the procedure and fluoroscopy time compared with non-CTO percutaneous procedures
The MED System™ Saves Crucial Time by Crossing Faster and Treating Where Other Devices Cannot Reach
Using breakthrough magnetic nano-technology, our Magnetically-Enhanced Diffusion (MED) System may support the crossing of CTOs by penetrating the CTO micro channels thereby allowing for faster wire crossing and faster over-all treatment. The MED therapy is also demonstrating the ability to treat below the knee clot as well as improved reperfusion of the distal vasculature. With more clinical evidence, MED has the potential to significantly reduce amputation rates (improved outcomes) though the use of magnetically enhanced nanoparticles accessing vasculature today’s devices cannot reach.
Time is of the essence when it comes to blood clots.
Recanalization in Acute Ischemic Stroke
During a stroke, every minute counts: the blood clot in the brain blocks vital blood flow. Each year, 800,000 people suffer strokes in the USA. Globally, stroke is a leading cause of disability and death, impacting over 10 million people.
A standard of care is to deliver the powerful clot-busting drug, Tissue Plasminogen Activator (tPA). tPA is the only FDA-approved thrombolytic therapy and since 1996, has remained a “gold standard” for recanalization (restoring normal blood flow).
Even as stroke devices gain acceptance as the new “gold standard,” today’s devices are limited by their mechanical properties. Today’s devices can rarely reach beyond M1 segments which means clot issues much deeper in the brain are left untreated which has life altering consequences.
The MED System™ Saves Crucial Time
Traditional delivery of tPA is hindered by stagnant flow. Fluidic barriers hinder fast and reliable therapeutic delivery which can result in greater disability or death.
To avoid irreversible damage and save lives, healthcare providers only have a small window of time deliver tPA treatment after clots develop in Acute Ischemic Stroke.
Using breakthrough magnetic nano-technology, our Magnetically-Enhanced Diffusion (MED) System may support the delivery of blood clot-busting tPA drug at a faster rate than traditional methods. Our MED system will also allow physicians to treat beyond the M1 and M2 branches allowing for deeper therapy.
Accelerating Treatment within Critical 3 Hour Timeframe
Pulse MED™ System Application in Acute Ischemic Stroke
In this video, normal diffusion is compared with diffusion using the MED System.
Due to fluidic barriers, normal diffusion resulted in the drug never reaching the end, despite infusion of over 2 hours.
With The MED™ System, the drug reaches end in less than 15 minutes.
How the Pulse MED System Works
A Nanotechnology Drug Delivery Platform
Pulse's breakthrough technology improves the fluidity of blood vessels that have become stagnant from clots. The MED System employs an external magnetic field that directs intravenous MicroBeads™ and clot busting drugs faster than traditional methods.
MED Magnet Workstation™
The MED System™ accelerates treatment. The workstation, placed near the patient's head, spins the magnet rapidly, helping to restore flow to obstructed blood vessels.
- Procedure designed to match 1-hour thrombolysis
- Administer treatment in the ER or patient room; no specialist needed
- Workstation is touch-screen operated, lightweight and portable
MED Intravenous MicroBeads™
- Infused after thrombolysis initiated
- Engineered to deliver tPA drug to the clot faster
- MicroBead structures disintegrate when flow is restored
Magnetically-Enhanced Mixing
MicroBeads become rotating stir rods directed by the system's magnetic field, enabling flow to be restored.
- Create a new fluidic current by rotating with the magnetic field
- No tissue/bone compensation
Results: Restoring Flow to Obstructed Vessels
Pulse MED™ uses a rotating external magnetic field and intravenously-injected, iron-oxide MED MicroBeads™ to accelerate delivery of clot-busting drugs and treat obstructed vessel current devices fail to reach.
- Proven to be significantly faster in treating clots; as a result, more effective in treating strokes
- Restores flow to stagnant blood vessels dramatically faster
- Based on 40+ years of clinical experience with intravenous iron, leveraging safety