SafeHeal(R) Receives European Marketing Approval Under MDR for Colovac(R) Anastomosis Protection Technology
14.8.2025 22:45:00 CEST | ACCESS Newswire | Press Release
Marketing approval allows imminent commercialization of the Colovac device in key EU markets
PARIS, FRANCE AND TAMPA, FL / ACCESS Newswire / August 14, 2025 / SafeHeal®, a leading innovator in the field of colorectal cancer surgery, today announced that it has been granted European Union marketing approval for its Colovac device under the new Medical Device Regulation (EU MDR 2017/745, Medical Devices, Annex IX Chapter I). This significant milestone confirms the company's compliance with the EU's rigorous safety and performance standards, enabling commercial distribution of Colovac across the European Union. Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal cancer resection.1,2
"This is a pivotal achievement for our company and a testament to the dedication of our regulatory, clinical, and engineering teams," said Chris Richardson, President and Chief Executive Officer of SafeHeal. "We are now ready to bring the clinical and economic benefits of Colovac to healthcare providers and patients throughout Europe."
The Colovac endoluminal bypass system is a less-invasive alternative to temporary diverting ostomy, the current standard of care for patients undergoing colorectal resection. Diverting ostomy is applied prophylactically to most patients today undergoing a low anterior resection (LAR) and anastomosis. The ostomy temporarily diverts the stool away from the healing anastomosis to the outside of the body and into an ostomy bag. In most cases, the ostomy is needed only until the anastomosis has healed, and then it can be reversed, typically after 2-6 months. The eventual reversal of the ostomy requires another operation, with a second hospital stay, recovery period and associated complications. In some cases, the ostomy may not be reversed and becomes permanent. In addition to the potential surgical complications associated with ostomy procedures, patients may experience an impact to their quality of life due to social isolation, reduced physical activity and/or intimacy.
Colovac is an alternative to diverting ostomy, designed to eliminate the need for a temporary stoma in most patients. It aims to improve patient recovery and quality of life by eliminating stoma related complications including permanent stoma and eliminating the physical and emotional burden associated with stoma management and care.
"Navigating the MDR process is no small feat for any company, and gaining approval affirms the strength of our technology and the robust data supporting it. After conducting a thorough review of the data supporting the performance and safety of the device and SafeHeal's quality management system, the EU Medical Device regulators wasted no time in recognizing the obvious clinical benefits Colovac provides to colorectal cancer patients," said Richardson.
Colovac has been successfully studied in the U.S., Europe, and Asia and the U.S. Food and Drug Administration (FDA) has already granted the product Breakthrough Device Designation. Breakthrough Device designation is granted to novel products and allows FDA to expedite the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
-
1 Intended Purpose: The Colovac Anastomosis Protection Device is intended for use in patients requiring low anterior rectal anastomoses to limit stoma creation to only those patients requiring more time for anastomosis healing when the device is removed, allowing patients with a healed anastomosis to avoid stoma creation.
2 Indication for Use: The SafeHeal Colovac Device is indicated for use following open, laparoscopic, or robotic-assisted laparoscopic colorectal surgery in patients indicated for diverting ostomy.
###
ABOUT SAFEHEAL®
SafeHeal SAS, headquartered in Paris, France, and its wholly owned U.S. subsidiary, SafeHeal Inc., is a medical device company developing Colovac, a device intended as an alternative to diverting ostomy in patients undergoing colorectal surgery. Colovac is a flexible endoluminal bypass sheath designed 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 approximately 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. In the U.S., Colovac is limited by Federal law to investigational use and not currently available for sale. For more information, please visit www.safeheal.com.
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
Vice President, International, SafeHeal
+33 (0) 6 5181 7895
kblohm@safeheal.com
www.safeheal.com
SOURCE: SafeHeal
View the original press release on ACCESS Newswire
SafeHeal
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Digi Power X Announces $200 Million Debt Financing Commitment to Support Completion of Alabama AI Data Center and Provides Expansion Update13.10.2026 13:30:00 CEST | Press Release
MIAMI BEACH, FL / ACCESS Newswire / October 13, 2026 / Digi Power X Inc. (Nasdaq:DGXX)(Cboe Canada:DGX) ("Digi Power X" or the "Company"), an AI data center infrastructure operator, today announced that it has received a commitment letter from a major lending institution for US$200 million in debt financing to support the development of its 40 MW AI data center in Columbiana, Alabama. The financing, syndicated by Goldman Sachs, is expected to close within 90 days, subject to definitive documentation and satisfaction of various conditions, including the lender's completion of its diligence efforts. The financing is to be structured at a project special purpose vehicle ("SPV") level, with an unsecured Company guarantee through project completion and other limited matters. Proceeds are intended to support completion of the Alabama project and related project costs, helping preserve corporate liquidity, mitigate shareholder dilution and position the Company to pursue additional customer co
Akkodis Brings Multilingual Intelligence to Mercedes-AMG PETRONAS Formula One Team races13.10.2026 06:45:00 CEST | Press Release
ZURICH / ACCESS Newswire / October 13, 2026 / Akkodis, a global leader in digital engineering consulting and part of the Adecco Group, today announced the deployment of a multilingual AI solution that enables international guests in the Mercedes-AMG PETRONAS Formula One Team Viewing Gallery to access real-time translated team radio and race commentary, event information and Formula 1 (F1) communications in their preferred language. Built using Akkodis' AI-Core system, the solution processes information directly at the circuit, delivering responsive, low-latency real-time transcription and translation services. The deployment highlights a growing shift in how organizations operate, bringing intelligence closer to where information is generated and decisions are made. Debuting at the Formula 1 Italian Grand Prix in Monza, the solution demonstrates how such systems can enhance real-world experiences in demanding, fast-paced and information-rich environments. For international guests in th
Chervon Names Charlie Harte Director of Field Sales & Recruiting - Canada12.10.2026 16:00:00 CEST | Press Release
NAPERVILLE, IL / ACCESS Newswire / October 12, 2026 / Charlie Harte joins Chervon as Director of Field Sales and Recruiting - Canada, effective Monday, October 12, 2026, reporting to Neil Harrison, VP/MD Sales and Marketing - Canada. Harte brings 15+ years of experience in the Canadian power tools, outdoor power equipment, and hand tool market. Additionally, he has 6+ years of experience selling into the commercial plumbing arena. Early in his career, Harte spent six years at Black and Decker growing into the National Sales and Marketing Manager position for B&D Canada. He subsequently became Director of Sales for Irwin Industrial Tools and then became a Director of Sales for Milwaukee Canada. Harte moved into the VP Sales position for Uponor Advanced Plumbing Solutions. Harte has an impressive track record in field sales leadership and strategic account development. He is known for his ability to build and manage high-performance sales teams throughout Canada. "Charlie brings an outst
Chervon Names Thomas G. Kentouris Vice President of Field Sales12.10.2026 15:00:00 CEST | Press Release
NAPERVILLE, IL / ACCESS Newswire / October 12, 2026 / Thomas G. Kentouris joins Chervon as Vice President of Field Sales, effective Monday, October 12, 2026, reporting to Matt DeFeo, SVP of Sales Training and Recruiting. Kentouris brings 14+ years of Power Tool and Outdoor Power Equipment experience at TTI. His career began as a sales rep and advanced through a series of increasingly responsible positions, culminating in SVP of Field Sales for Eastern U.S.A. Kentouris delivered exceptional sales growth results year after year in his areas of responsibility. His ability to develop store-level partnerships and store-level sell-through programs all resulted in exceptional levels of success. Kentouris distinguished himself as an outstanding recruiting talent as he and his teams were responsible for recruiting over 2,000 high potential recent college graduates into the TTI system. Kentouris did an amazing job mentoring, developing, and promoting hundreds of his people into higher level posi
Chervon Names Randall Durkan Vice President of Supply Chain - North America12.10.2026 15:00:00 CEST | Press Release
NAPERVILLE, IL / ACCESS Newswire / October 12, 2026 / Randy Durkan joins Chervon as Vice President of Supply Chain - North America, effective Monday, October 12, 2026, reporting to CEO Joe Galli. Randy Durkan brings over 25 years of supply chain management experience, including extensive leadership in power tools, hand tools, and outdoor power equipment. He has proven experience building high-performance supply chain teams and has consistently delivered outstanding service levels, inventory optimization, and cost-reduction results. Durkan is known for developing strong supply chain partnerships with key customers, driving cross-functional collaboration, and deploying technology to achieve world-class supply chain performance. He began his early supply chain career in Bentonville, Arkansas, supporting Walmart-focused collaboration across several consumer goods companies. His work at Vi-Jon contributed to Walmart's 2008 Supplier of the Year Award. Durkan then spent six years in supply ch
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom