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The following is just a small sampling of recent Neurovascular market updates from around the world compiled, reviewed and posted daily by our SmartTRAK analysts.
New Products:
- ZOOM* - Imperative Care*
Imperative Care announced the completion of first cases using the recently FDA-cleared Zoom 88 Support catheter. One of the cases was an AIS patient with a tandem occlusion treated at Erlanger Health System in Chattanooga, TN. SmartTRAK reported FDA clearance of the device on Jun 15.
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EOSolutions Launches Dr. Banner BGC
EOSolutions announced the full commercial launch of its Dr. Banner, Balloon Guide Catheter (BGC), developed in collaboration with InNeuroCo. According to the Company, the BGC features a 0.091 ID, proximal stability, distal trackability and a compliant polyurethane balloon.
Patents:
- phenox*
phenox GmbH’s US Patent Application “Insertion System For Implants For Treatment Of Bifurcation Aneurysms” was published disclosing a Y-shaped tubular implant and Y-shaped insertion catheter for bifurcation aneurysm treatment. 20230233347
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Aspiration Catheter with an Adjustable Tip
The Univ of Toledo’s US Patent Application “Aspiration Catheter With An Adjustable Tip For The Intracranial Circulation” was published disclosing a neurovascular aspiration catheter with an adjustable tip controlled by pull wires. 20230233221
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Microcather Path Generation for Aneurysm Treatment
Hangzhou ArteryFlow Technology’s US Patent Application “Microcatheter Path Generation Method, Shaping Method Of Mandrel, Computer Equipment, Readable Storage Medium And Program Product” was published re a vascular model to find a path from a starting point to an ICA. 20230210600
Studies:
- EVT for Large Ischemic Stroke
A systematic review and meta-analysis of 3 RCTs (N=1,011) evaluating EVT for large ischemic strokes demonstrated results that favored EVT over medical management and concluded EVT has a clear functional benefit and does not increase the risk of significant complications. Neurosurgery -
Route 92
A 36-patient 2-year single-center experience with Route 92’s triaxial catheter assembly and HiPoint 0.088” LBC reported* 26 patients were treated with the 0.088” LBC alone. Single pass mTICI 2C/3 was achieved in 22 cases, and all patients had mTICI ≥ 2B. SNIS 2023 E-poster -
JNJ/DePuy Synthes*
A CERENOVUS-supported E-poster presented* the results of a Delphi method consensus from the 2022 CLOTS 7.0 Summit that describes what a challenging clot could be and suggests technique should be switched after 3 failed MT passes. SNIS 2023 E-poster
Deals/Financing:
- RapidAI Announces $75MM Series C Funding
RapidAI announced $75MM in Series C funding led by Vista Credit Partners. The funding aims to drive platform innovation to support more disease states and go-to-market functions to accelerate growth in new regions and product verticals.
- Shape Memory Medical Sublicenses Tech Outside Vascular Focus
Shape Memory Medical entered into an agreement with an undisclosed global medtech company to sublicense its proprietary shape memory polymer tech for a narrow indication in a therapeutic area outside of Shape Memory Medical’s cardio-, endo- and neurovascular focus. - Sensome and Asahi Intecc to Develop Next-gen Smart Guidewire
Sensome and Asahi Intecc are collaborating to develop the next-gen Clotild Smart Guidewire, with Asahi Intecc in a manufacturing role. The Clotild Smart Guidewire uses Sensome's AI-driven tissue microsensor to provide clot information to physicians during thrombectomy procedures.
Clinical/Regulatory:
- Development of AI for Video-based Stroke Detection
A 300-patient clinical trial in France will aim to develop a collection of videos to enable the creation of artificial intelligence algorithms for early stroke diagnosis via self-testing with the AI-STROKE mobile device app. Estimated study completion is Dec 2024. clinicaltrials.gov - Acandis*
A 150-patient clinical trial in Vietnam in collaboration with Acandis GmbH will assess the use of the Credo stent in the treatment of symptomatic intracranial stenosis based on rates of stroke at death and 1-with f/up. Estimated study completion is Oct 2024. clinicaltrials.gov
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Two vs One Stent Retriever for AIS Thrombectomy
A 200-patient clinical trial will compare the effectiveness and safety of the use of 2 SRs simultaneously vs one SR as a first-choice treatment for AIS thrombectomies. Est study completion is July 2024. clinicaltrials.gov
Markets:
- Mechanical Thrombectomy - US*
Due to research on MT in other AIS patients (e.g., low ASPECTS, late time window, posterior circulation, etc.), the number of US AIS patients who are potential MT candidates is projected to increase from ~247,140 in 2022 to ~258,909 in 2027E. SmartTRAK Mechanical Thrombectomy Market Overview*
- Microbot Medical Working Towards LIBERTY Clearance in Europe Microbot Medical announced it has engaged with a leading Notified Body that will audit the Company to verify the compliance of its quality management and the LIBERTY Robotic Surgical System development. Preparations are also being made to obtain EU-MDR certification and CE mark.
- SmartTRAK Did You Know?
RapidAI has partnered with hospitals in India, including Bengaluru and Mumba. Apul Nahata, India head and VP-engineering of RapidAI, told Analytics India Magazine that for a country such as India, AI can bring a massive value add.
Revenues:
- Medtronic*
For Q4FY23, MDT’s Specialty Therapies saw broad-based strength on LDD growth in NV and ENT and MSD growth in Pelvic Health. MDT Q4FY23 Earnings Release AXNX Q223 Earnings Release
- MicroPort*
In 2022, MicroPort’s overseas neurovascular revenue surpassed $3MM for the first time, with revenue mainly coming from the US, Korea and Europe. MicroPort Scientific 2022 Annual Report
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Penumbra*
PEN increased its guidance for FY23 to be in the range of $1.04B to $1.06B, representing +23% to +25% growth over FY22 revenue of $847.1MM. PEN expects vascular biz growth to be slightly above this range and neuro biz growth to be below this range. PEN Q123 Earnings Release
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