The Need
According to CDC statistics, stroke is the third leading cause of death in the United States. Over 140,000 people die each year from stroke. The most common cause of stroke is Atrial Fibrillation (AF).
Millions of people are admitted each year to Neurologic Intensive Care Units (NICUs) with stroke.
Once evolved, there are limited measures, available only during the first few hours, to prevent patient deterioration.
Commonly, stroke patients are unable to speak, walk, and think coherently. Occasionally, patients cannot breathe independently, and most patients are left with debilitating neurological deficits.
Oral Anticoagulants (OACs) are currently the primary standard of care for stroke prevention.
Despite OACs being recommended for high-risk patients, they require patients’ compliance and are commonly associated with complications:- Hemorrhagic stroke
- Gastrointestinal bleeding
- Interaction with other drugs and increased risk of toxicity
- The need for daily treatment commonly causes low patient compliance, further limiting the efficacy of OACs
- Uncertain effects and safety in patients with advanced renal failure and valvular diseases (for new OACs)
- Teratogenicity (Coumadin)
The SYNAXIS stent is a groundbreaking Embolic Protection Device (EPD) that directly diverts blood clots from the cranial branches thus preventing stroke. The system offers both short-term and long-term protection from stroke while maintaining full perfusion of blood to the brain.
The SYNAXIS EPD system is composed of a designated aortic arch implant equipped with a built-in filtering unit, both are delivered in a minimally invasive manner using a state-of-the-art delivery system that ensures accurate deployment and positioning.
The SYNAXIS catheter, using a standard procedure, is inserted into the aortic arch by a cardiac surgeon, cardiologist or invasive radiologist. The system’s dedicated filtering unit is composed of cutting-edge materials that prevent neointima proliferation and thrombosis.
SYNAXIS Technology & IP
SYNAXIS Technology & IP The InVatin proprietary technology is the revolutionary EPD system, which directly prevents emboli injury to the brain. The system enables long-term embolic protection in patients with intra-cardiac thrombi who cannot be treated with OACs and Left Atrial Appendix Closure Devices (LAACD).
Provisional and international PCT patent applications have been filed to protect all components of the SYNAXIS system. Some of the preclinical results were published in a peer reviewed medical literature (J Cardiovasc Transl Res. 2019).
Advantages
The SYNAXIS stent prevents the need for OAC treatment
- Patients can return to their day-to-day activities without the risk of life-threatening bleeding
- No need for frequent blood tests
- Prevents OAC-related complications and morbidity
- Enhanced patient safety & treatment compliance
- Improved quality of life
Unique Indications
Procedural Benefits
Long Terms Benefits
Competitive Pricing
