Surmodics Announces Successful Early Clinical Use of Pounce™ LP (Low Profile) Thrombectomy System, Designed to Address a Critical, Unmet Need by Facilitating Removal of Thrombi and Emboli Below the Knee
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Insights
The introduction of Surmodics' Pounce LP Thrombectomy System signifies an advancement in the treatment of peripheral arterial disease (PAD), particularly in below-the-knee (BTK) interventions. The system's ability to address clots in smaller vessels, which are often difficult to navigate and treat, represents a significant enhancement over previous technologies. This could lead to increased demand for Surmodics' thrombectomy devices, potentially boosting the company's market share in the PAD treatment sector.
From a financial perspective, the successful early clinical use and upcoming full commercial launch may positively influence Surmodics' revenue streams. The device's FDA clearance and its complement to the existing product line could attract attention from investors, as it demonstrates the company's commitment to innovation and expansion within its portfolio. As PAD affects millions globally, the market potential for effective BTK interventions is substantial and Surmodics appears poised to capitalize on this opportunity.
The Pounce LP Thrombectomy System's ability to remove thrombi from small-diameter vessels below the knee is a notable clinical advancement. The system provides a minimally invasive option compared to traditional surgical embolectomy, which can be crucial for patients with comorbidities or those at high risk for surgery. The device's efficiency in removing acute and subacute thrombus without the need for thrombolytics or causing embolization is a key benefit, potentially reducing procedure time, recovery duration and overall healthcare costs.
For patients with critical limb ischemia, a condition that often results in amputation if left untreated, the Pounce LP System could offer limb salvage opportunities. This has profound implications for patient quality of life and healthcare outcomes. As a vascular surgeon, the ability to provide effective BTK revascularization with a lower risk profile is a significant addition to the treatment armamentarium.
The Pounce LP Thrombectomy System's entry into the market comes at a time when there is a growing emphasis on minimally invasive procedures. The system's target of small-diameter peripheral arteries, a niche yet critical segment, allows Surmodics to address unmet medical needs. This strategic positioning could enable the company to establish a strong foothold in a competitive landscape.
Market trends indicate an increasing prevalence of PAD, driven by aging populations and the rise of diabetes and obesity. The Pounce LP System's ability to mitigate the risks associated with BTK interventions could lead to broader adoption by healthcare providers. It is important to monitor the system's performance during the limited market evaluation phase, as this will provide valuable data on efficacy and safety that can influence broader market acceptance and adoption rates.
Addition of a low-profile device to the Surmodics Pounce™ thrombectomy platform allows for efficient clot removal in peripheral arteries ranging from 2 mm to 4 mm, such as those found below the knee
Surmodics’ Pounce Thrombectomy devices are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter, sizes typical of vessels found below the knee. The Pounce LP System complements the original Pounce Thrombectomy System, introduced in 2021, which is indicated for use in vessels 3.5 mm to 6 mm in diameter.
Dr. Lucas Ferrer Cardona,* a vascular surgeon with the Dell Seton Medical Center at the University of Texas Hospital in
“In our first use of the device, the Pounce LP Thrombectomy System performed exceptionally well in helping our team restore blood flow to the foot for a limb-threatened patient,” he said. “Using the device, we promptly removed acute and subacute thrombus from the mid-peroneal artery below the knee with no adjunctive use of thrombolytics and no embolization. Thrombi or emboli in below-the-knee vessels have traditionally been very challenging to remove. I believe this device holds great promise in filling a major gap in our treatment algorithm.”
Dr. Elizabeth Genovese, a vascular surgeon at the Hospital of the University of
“The Pounce LP System allowed me to treat chronic thrombus in these vessels with the effectiveness I’d expect from open surgical Fogarty embolectomy while maintaining the advantages of an endovascular approach for treating underlying and distal disease,” she said. “We were able to achieve an optimal outcome in a very complex lesion, and this type of result would not have been possible without this device.”
“We’re very pleased with the successful early clinical use of the Pounce LP Thrombectomy System, which will extend the range of treatment for our Pounce platform to include removal of organized thrombotic or embolic clots from the iliac arteries in the pelvis down to tibial vessels below the knee,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “Downstream embolization of chronic material into below-the-knee arteries during an endovascular procedure can be an interventionist’s nightmare, sometimes requiring surgical rescue. The Pounce LP System’s ability to capture and remove these unexpected emboli adds yet more value to this device for BTK revascularization.”
About the Pounce Thrombectomy Platform
The Pounce System is the first mechanical thrombectomy device designed to remove acute-to-chronic thrombi and emboli in occluded peripheral arteries without the need for capital equipment or aspiration and minimizing the use of thrombolytics. Described as a “grab-and-go” solution, the Pounce System is both readily deployable and simple to use. The System is composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the System is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body. The Pounce Thrombectomy platform includes two different-sized devices: the original Pounce™ Thrombectomy System, indicated for use in peripheral arterial vessels 3.5 mm to 6 mm in diameter, and the Pounce LP (Low Profile) Thrombectomy System, indicated for use in peripheral arterial vessels 2 mm to 4 mm in diameter.
In a retrospective study 3 of 44 consecutive patients treated for lower extremity limb ischemia with suspected thrombus using the original Pounce System (acute, subacute, and chronic clot), investigators achieved
About Surmodics, Inc.
Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements regarding what the Pounce LP Thrombectomy System is designed to address, the planned full commercial launch of the product, the promise of the product, and Surmodics’ strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the results of the limited market evaluation of the Pounce LP Thrombectomy System, adoption of the product, and the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2023, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
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* Consultant for Surmodics
- Gray BH, Wheibe E, Dicks AB, Low ML, Tingen JS. Pounce Thrombectomy System to Treat Acute and Chronic Peripheral Arterial Occlusions. Ann Vasc Surg. 2023;96:104-114.
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Source: Surmodics, Inc.
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