Stroke Rates May be Underreported in Recent Clinical Trials​​

Dire Clinical Need: Embolic Debris Evident in Up to 99% of Patients​​

Ulrich Schäfer, M.D.
Interventional Cardiologist,
University Hospital Hamburg (Germany)​

TAVR Shifting to Younger and Lower-Risk Patients
Cerebral protection becomes even more important with TAVR shifting  toward younger and lower-risk patients. Recent clinical data from intermediate-risk patients undergoing TAVR suggest 30-day stroke risk up to 5.5%.

CAUTION: The ProtEmbo Cerebral Protection System is approved for investigational use in Europe.    ​​

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Most Clinical Cerebrovascular Events Are Periprocedural
Most of the clinical cerebrovascular events occur during the TAVR procedure (≥50%) or on the day of the procedure; Most of these events are ischemic (>95%); No anti-coagulation therapy can resolve this issue completely.





Sources: Kodali, S. SENTINEL – A Prospective, Randomized Trial Evaluating Cerebral Protection in Patients with Severe AS Undergoing TAVR. TCT 2017; Lansky, A. The Neuro-TAVI Trial. PCR London Valves 2015; Nombela-Franco et al., Circulation 2012;126:3041-53.

What the Clinicians are Saying about ProtEmbo

Stroke rate is 15-27% after TAVR by current AHA/ ASA definitions

Improve Patient Care and Reduce Cost for Health Care Systems
Cost of clinical cerebrovascular events are as high as € 100,000 per patient (average lifetime cost). The use of cerebral protection devices in every TAVR procedure is not only beneficial for the patient’s brain, but also is less costly for the healthcare system – assuming currently reported cerebrovascular event rates.

Darren Mylotte, M.D.
Interventional Cardiologist,
University Hospital Galway (Ireland)

30-day stroke rates in recent TAVR randomized controlled trials