• 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
      Antibacterial Peptide Spray Safe for Use on Wounds

      Antibacterial Peptide Spray Safe for Use on Wounds

      Flexible Sensors Detect Heavy Metals in Sweat

      Flexible Sensors Detect Heavy Metals in Sweat

      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

    • Radiology
      Tiny Patch for Cardiac Ultrasound Imaging

      Tiny Patch for Cardiac Ultrasound Imaging

      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Fluorescence Imaging System Illuminates Tumor Depth

      Fluorescence Imaging System Illuminates Tumor Depth

    • Cardiology
      Tiny Patch for Cardiac Ultrasound Imaging

      Tiny Patch for Cardiac Ultrasound Imaging

      Belt Monitors Heart Failure Patients

      Belt Monitors Heart Failure Patients

      Camera Measures Blood Pressure with Quick Look

      Camera Measures Blood Pressure with Quick Look

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

    • Surgery
      Antibacterial Peptide Spray Safe for Use on Wounds

      Antibacterial Peptide Spray Safe for Use on Wounds

      Microneedle Bandage for Hemostatic Control

      Microneedle Bandage for Hemostatic Control

      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

    • Nanomedicine
      Extra Hot Nanoparticles for Cancer Therapy

      Extra Hot Nanoparticles for Cancer Therapy

      Making Tumors Tastier for the Immune System

      Making Tumors Tastier for the Immune System

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Magnetic Bacteria Target Tumors

      Magnetic Bacteria Target Tumors

    • Military Medicine
      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

      Fabric Makes Electricity from Movement to Power Wearables

      Fabric Makes Electricity from Movement to Power Wearables

      Wearable Uses Microneedles to Track Metabolism

      Wearable Uses Microneedles to Track Metabolism

    • Rehab
      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Implanted Magnets for Prosthetic Control

      Implanted Magnets for Prosthetic Control

  • 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

SafeHeal Announces Successful Launch of IDE Study for Colovac Endoluminal Bypass Sheath

April 5th, 2022 SafeHeal Releases

SafeHeal™, a leading innovator in the field of digestive surgery, recently announced the first patient enrollment in its pivotal study of Colovac™, a groundbreaking endoluminal bypass sheath. Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal resection. Up to 20 U.S. and European sites will enroll patients in the study.

Tampa General Hospital, Tampa, Fla., under the direction of site Principal Investigator Jorge Marcet, MD, professor of the Department of Surgery and director, Colon and Rectal Surgery at the USF Health Morsani College of Medicine and colon and rectal surgeon at Tampa General Hospital’s Cancer Institute successfully performed the study’s first enrolled patient, and the first-ever Colovac procedure in the U.S.

“We are excited to be the first investigative site in the U. S. to enroll patients in SafeHeal’s clinical trial of the Colovac device,” said Dr. Marcet. “Treatment of rectal cancer most often involves radiation and chemotherapy followed by surgical removal of the rectum. Because the risk of non-healing of the bowel anastomosis is high, and the consequences could be dire, the surgeon temporarily diverts the stool from the anastomosis by creating an ostomy. The patient keeps the ostomy for about 2-6 months, and the eventual reversal of the ostomy requires another operation, hospitalization, and recovery period. The aim of the SafeHeal study is to see if these patients can safely avoid an ostomy and avoid additional operations.”

“Our initial experience with this device is positive and we are excited to be able to offer this cutting-edge technology to our patients as part of the study.” Principal Investigate Jorge Marcet, MD

“We are intently focused on providing the safest and most innovative care for patients with colorectal cancer, which is why we are always eager to participate in clinical trials.”

The SAFE-2 randomized controlled IDE study will assess the safety and efficacy of the Colovac endoluminal bypass sheath in adult patients who were initially scheduled to receive a diverting ostomy following colorectal surgery. Diverting ostomy, the current standard of care, is applied prophylactically to most patients today undergoing a low anterior resection (LAR) and anastomosis, due to the high risk of anastomotic leak in this patient cohort. Anastomotic leakage, or an incomplete healing of the anastomosis, occurs in up to 20 percent of patients undergoing LAR. It is one of the most serious complications of colorectal surgery, frequently resulting in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and potential mortality.

“Participating in a study of this caliber for a potentially groundbreaking advance in the care of colorectal surgery patients aligns with our vision to be the safest and most innovative academic health system in America,” said Dr. Abraham Schwarzberg, chief of oncology and senior vice president of network development, Tampa General.

Following successful pilot studies completed in Europe, SafeHeal will conduct the SAFE-2 study at 25 leading academic medical centers in the United States and Europe. Patricia Sylla, MD, professor of Surgery at the Icahn School of Medicine at Mount Sinai in New York City, is the overall SAFE-2 Principal Investigator. Dr. Sylla serves as a paid consultant to SafeHeal.

“Many of us are very excited about this multicenter, international study that just kicked off in the U.S. The study is designed to evaluate whether most patients undergoing rectal cancer surgery can safely avoid a ‘protective ileostomy’ by having a protective sheath placed instead for just 10 days.

“If the results confirm preliminary data from Europe, this novel device may alter standard practice, and improve the quality of life for a significant proportion of our patients.” Patricia Sylla, MD

Every year, approximately 500,000 patients worldwide undergo low anterior resection surgery, defining the broad opportunity for the Colovac device to significantly improve patient outcomes and recovery.

“The initiation of our SAFE-2 study represents the achievement of a critical milestone in our path to eventual FDA market approval and making a positive impact in the care and quality of life of colorectal surgery patients.” SafeHeal CEO Karl Blohm

 

ABOUT SAFEHEAL

SafeHeal SAS, headquartered in Paris, France, and its wholly-owned U.S. subsidiary, SafeHeal Inc., is a clinical-stage medical device company which develops Colovac, a device invented by a French digestive surgeon, Dr. Charam Khosrovani, to obviate the need for a digestive ostomy in patients undergoing colorectal surgery. Colovac is a flexible bypass sheath intended to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed endoluminally and is fully reversible. The device remains in place for 10 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure without the need for a second surgical intervention. This enables patients to resume their normal life without the stigma and complications associated with an ostomy procedure. Colovac is an investigational device, not currently available for sale.

MEDIA CONTACTS

USA
Scott DePierro
Vice President U.S. Operations
and Global Business Development, SafeHeal

203-444-0279
sdepierro@safeheal.com
www.safeheal.com

Europe:
Karl-Heinz Blohm
CEO, SafeHeal

+33 (0) 6 5181 7895
kblohm@safeheal.com
www.safeheal.com

 

 

Sign up and submit a press release

Sponsored
C-mo Medical Solutions extends seed investment round to €4.8 million to transform cough monitoring

C-mo Medical Solutions extends seed investment round to €4.8 million to transform cough monitoring

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

Fluidx Unveils New Embolic for Neurovascular Use

Fluidx Unveils New Embolic for Neurovascular Use

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

PT Genie Unveils New Brand Identity Reflecting Company’s Transformation and Focus on the Global Future of AI and Machine Learning in Digital Healthcare

interviews & reviews
Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

  • 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!
Posting....
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email