Business Wire

RAPID-MEDICAL

26.7.2022 22:00:11 CEST | Business Wire | Press release

Share
Rapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 13 is the smallest revascularization device in the world to date and is designed to remove thrombus from delicate brain blood vessels during an ischemic stroke. It is the only device that adjusts to the vasculature and clot, a more atraumatic approach than existing devices.

“The neurovascular field has been waiting for a thrombectomy device dedicated to small vessels,” states Dr. David Fiorella of Stony Brook University Medical Center in Stony Brook, NY. “Medical therapy is currently suboptimal for these patients, so there can be a huge benefit for devices that emergently restore blood flow while minimizing the potential for harm.”

Existing stent retrievers lack any adjustability­– they open passively and are pulled from the brain fully expanded. The unique adjustability of the TIGERTRIEVER portfolio comes from complex three-dimensional braiding borrowed from recent advances in aerospace engineering. TIGERTRIEVER is precisely controlled to capture the thrombus and remove the tension from the vasculature before removal. Adjustability also gives TIGERTRIEVER 13 the lowest profile of any stent retriever—24% smaller than 3 mm devices, providing easier navigation in challenging anatomies. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

“Thousands of procedures have already been performed with TIGERTRIEVER 13 worldwide,” describes James Romero, President, Americas, of Rapid Medical. “Now U.S. physicians finally have access to TIGERTRIEVER 13’s unique capabilities to further benefit patients suffering from ischemic stroke.”

About Rapid Medical
Rapid Medical develops the premier, responsive interventional devices for neurovascular diseases such as ischemic and hemorrhagic stroke. Utilizing novel manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the intravascular environment and have greater control over procedural outcomes. TIGERTRIEVER ™17 and 21, COMANECI ™, and COLUMBUS™/DRIVEWIRE are CE marked and FDA cleared. TIGERTRIEVER™13 and XL are also CE marked. More information is available at www.rapid-medical.com .

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release

If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids

Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 13:00:00 CEST | Press release

Recommendation based on TROPION-Breast02 phase 3 trial where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival If approved, Datroway has potential to be the first TROP2 directed antibody drug conjugate for patients in EU with a demonstrated overall survival benefit as first-line treatment Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use

DAYBU®(trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 12:49:00 CEST | Press release

-- European Commission decision expected in the coming months-- If approved, DAYBU®would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating

HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 11:18:00 CEST | Press release

HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi

Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 10:28:00 CEST | Press release

Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye