Haemonetics Launches Limited Market Release for New VASCADE MVP XL Vascular Closure Device
Haemonetics (NYSE: HAE) has launched a market release of its new VASCADE MVP XL, a mid-bore venous closure device. This device is an extension of the VASCADE portfolio, featuring a collapsible disc and a resorbable collagen patch for rapid hemostasis. The VASCADE MVP XL system utilizes 58% more collagen and is designed for larger procedural sheaths up to 15F in outer diameter. It targets procedures like cryoablation and left atrial appendage closure for atrial fibrillation patients. The device has received pre-market approval from the FDA and the first procedure has been successfully performed by Dr. Tom McElderry at the University of Alabama at Birmingham. Haemonetics aims to capture a share of the $2.7 billion vascular closure market and plans a full market release later this year.
- Launch of new VASCADE MVP XL, expanding the VASCADE portfolio.
- Targeting the $2.7 billion vascular closure market.
- FDA pre-market approval received.
- First successful procedure performed by Dr. Tom McElderry.
- 58% more collagen and larger disc enhancing closure capabilities.
- Full market release anticipated later this year.
- market release indicates possible initial production constraints.
Insights
The launch of the VASCADE MVP XL system reflects Haemonetics' strategic move to diversify and strengthen its product range in the vascular closure device market. The VASCADE MVP XL's ability to handle larger sheath sizes (10-12F, up to 15F in outer diameter) makes it suitable for complex procedures such as cryoablation and left atrial appendage closure, which are critical in treating atrial fibrillation patients. This is significant because atrial fibrillation is a common and serious cardiac arrhythmia affecting millions globally. By enhancing procedural safety with a more robust closure solution, Haemonetics is likely to gain a competitive edge.
From a clinical perspective, the increased collagen content and larger disc are designed to promote rapid hemostasis, which can lead to quicker recovery times and potentially fewer complications post-procedure. This is particularly important in high-risk cardiac patients where reducing recovery time can significantly impact overall patient outcomes. Moreover, the pre-market approval from the FDA underscores the device's compliance with stringent regulatory standards, enhancing its credibility and acceptance in the medical community.
However, it's noteworthy that the current release is limited, which may delay widespread adoption and revenue realization until the full market release later in the year. This phased approach, while cautious, allows Haemonetics to gather initial feedback and make necessary adjustments before a broader rollout.
The introduction of the VASCADE MVP XL aligns with Haemonetics' strategy to tap into the
One potential advantage for Haemonetics is the first-mover benefit in addressing this particular segment of the vascular closure market. Competitors may follow suit, but Haemonetics' early entry gives it the opportunity to establish a solid foothold. Furthermore, the limited market release can serve as a pilot phase to refine marketing strategies and product support based on real-world feedback, which can be important for a successful full market release.
On the flip side, the success of this product will depend on its clinical performance and the reception by medical professionals. If the device meets or exceeds expectations, it could lead to significant revenue growth. Conversely, any negative feedback during the limited release phase could impact its market potential.
Haemonetics' current VASCADE portfolio includes the VASCADE system, designed for "small-bore" femoral arterial and venous closure with standard 5-6/7F procedural sheaths, and the VASCADE MVP® system, designed for "mid-bore" multi-access femoral venous closure with 6-12F procedural sheaths. The upsized VASCADE MVP XL system utilizes
"With VASCADE MVP XL, Haemonetics continues to expand its presence and broaden its reach in the
The VASCADE MVP XL system earned pre-market approval from the U.S. Food and Drug Administration this spring. The limited market release follows the first procedure performed using VASCADE MVP XL by Dr. Tom McElderry, Section Chief, Electrophysiology and Co-Director Heart & Vascular Center at the University of
About Haemonetics
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services. Haemonetics' Global Hospital business provides a range of solutions to address the needs of hospitals, including Interventional Technologies for electrophysiology and interventional cardiology, and Blood Management Technologies that include diagnostics to help inform treatment decisions, technologies to help avoid unnecessary allogeneic transfusions and solutions to help optimize management of blood products. To learn more about Haemonetics, visit www.haemonetics.com.
Cautionary Statement Regarding Forward-Looking Information
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the Vascade MVP XL vascular closure device and Haemonetics' plans or objectives related to the commercialization of such product. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics' current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of global economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the
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SOURCE Haemonetics Corporation
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