• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Cancer Organoids Offer Insights into Treatment Outcomes

      Cancer Organoids Offer Insights into Treatment Outcomes

      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Laser-Based Breath Analysis Detects COVID-19 Infection

      Laser-Based Breath Analysis Detects COVID-19 Infection

      Technique Reveals 3D Genome Interactions

      Technique Reveals 3D Genome Interactions

    • Radiology
      Implanted Ultrasound Lets Chemo Access Brain

      Implanted Ultrasound Lets Chemo Access Brain

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

      RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

    • Cardiology
      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Chest Wearable Provides Key Heart Measurements

      Chest Wearable Provides Key Heart Measurements

      Vein on a Chip Includes Flexible Valves

      Vein on a Chip Includes Flexible Valves

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

    • Surgery
      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Stimulating Wounds with Electricity for Rapid Healing

      Stimulating Wounds with Electricity for Rapid Healing

    • Nanomedicine
      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Get Lymphatic Vessels Pumping

      Nanoparticles Get Lymphatic Vessels Pumping

      Bottlebrush Particle for Synergistic Drug Combinations

      Bottlebrush Particle for Synergistic Drug Combinations

    • Military Medicine
      Wearable Can Take Multiple Sweat Samples

      Wearable Can Take Multiple Sweat Samples

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

    • Rehab
      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

ProtEmbo for Reducing Strokes Caused by TAVR Procedures: Interview with Founders

March 10th, 2020 Cici Zhou Cardiac Surgery, Cardiology, Exclusive, Neurology

During transcatheter aortic valve replacements (TAVR), there is a risk of cerebrovascular events due to embolic debris breaking off from vessel walls and migrating to the brain. While microembolization during the procedure is a universal phenomenon, the majority of patients experience no symptoms. However, a clinically-evident stroke is a serious and feared complication.

Protembis is developing a solution that will hopefully reduce the incidence of post-TAVR cerebrovascular events. The Aachen, Germany-based company’s ProtEmbo device is an embolic protection filter designed for placement in the aortic arch, at the base of the three large vessels leading to the brain. The filter is placed via the left radial artery before the TAVR procedure begins and removed at its conclusion.

We asked the founders and Co-CEOs Conrad Rasmus and Karl von Mangoldt about their company and ProtEmbo.

Cici Zhou, Medgadget: Tell us how Protembis started. What was the inspiration behind the company and ProtEmbo?

Protembis: Our company Protembis was founded based on the vision to provide a simple solution to protect patients undergoing transcatheter aortic valve replacement (TAVR) from the risk of suffering a stroke. One of the co-founders is an interventional cardiologist who had seen stroke occur during these procedures and as a result of it looked more carefully at his patients’ brains pre- and post-procedure. What he saw convinced him that cerebral protection is absolutely necessary for better patient outcomes after these procedures. We have built a team of great people with clinical, technical, regulatory and business backgrounds to bring this idea to reality. What began as a drawing on a napkin soon became a patent application and today a fully functional medical device at clinical investigation stage.

Medgadget: What is the ProtEmbo made of? Does it affect blood flow through the aortic arch vessels?

Protembis: The ProtEmbo System is a temporary use, intra-aortic embolic protection filter device for single use, implantable as an adjunctive device at the beginning of a TAVR procedure and removed following the completion of the procedure. The ProtEmbo System comprises a filter which is connected to a delivery unit enabling delivery of the unexpanded device via a catheter and placement in the aortic arch of a patient. The filter consists of a porous polymeric material with 60µm pores that allows free passage of blood cells but blocks critical embolic particles from entering the three side branch vessels leading to the brain.

In our first-in-human study we observed a very positive effect of ProtEmbo on patient’s brains with a reduction of circa 50% in brain lesion burden compared to patients without cerebral protection. When adjusting for pre-procedural lesion burden the ProtEmbo showed an up to 90% reduction.

Medgadget: How does usage of the ProtEmbo affect the surgery workflow or introduce any additional surgical risks?

Protembis: The ProtEmbo System is a very intuitive adjunct device to be used during TAVR. It can be delivered through a commercially available 6F sheath via the left arm of a patient. The vascular access for ProtEmbo can be conducted while the patient is being prepared for TAVR. The ProtEmbo vascular access is isolated from all other interventional equipment, leaving especially the groin femoral access free for any kind of combined interventional procedures. Placement of the filter is extremely quick and easy, adding no significant time to the overall procedure. Also, using the left radial access entails fewer risks such as bleeding and use of additional closure devices.

Medgadget: At what stage is the company today?

Protembis: Today, Protembis has a team of 10+ people and is preparing a European clinical study with its next generation ProtEmbo System. The most recent funding was completed in late 2018 with a $10 million Series A financing round. A syndicate consisting of VCs, family offices and medtech angel investors together with US medtech company Abiomed Inc. had invested back then. This last funding round secures the next steps through CE marking of the ProtEmbo System.

Medgadget: What are some of the biggest challenges facing the team over the next few years?

Protembis: The biggest challenge for us – as for any medtech startup at a comparable stage – is certainly the transition to Medical Devices Regulation (MDR). We at Protembis have taken the strategic decision not to attempt slipping through under Medical Device Directive (MDD) but to undergo the conformity assessment for our product under MDR. This entails additional hurdles but we see this as a competitive advantage for our company. MDR brings requirements closer to FDA standard and will increase confidence in our products. Following CE mark approval, Protembis plans to conduct a larger clinical trial in the United States for FDA approval of the ProtEmbo.

Check out this video on how ProtEmbo works:

Link: Protembis homepage…

Cici Zhou

Cici Zhou is currently a resident physician at Kaiser Permanente. In the past, she has done management consulting for medical startups and worked as a researcher at UC San Francisco. As a physician, she's excited by the intersection of medicine + technology because of its ability to completely transform the industry and touch millions of lives.

Sponsored

Packaging Compliance Labs (PCL) Celebrates Site Expansion in Grand Rapids, MI

Novel Approach to Assessing Lung Function Enables Improved Detection, Diagnosis and Treatment Decisions in Subject Exposed to Military Burn Pits

U.S. Patent Office Grants Additional Patent Protection For  Exoskeleton Focal-Force Angioplasty Platform

U.S. Patent Office Grants Additional Patent Protection For Exoskeleton Focal-Force Angioplasty Platform

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

interviews & reviews
Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Imagene Profiles Cancer Biomarkers in Real Time

Imagene Profiles Cancer Biomarkers in Real Time

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email