Haemonetics' VASCADE MVP® XL System Gains FDA Approval for Expanded Use
Haemonetics Corporation, a leader in medical technology, has announced the U.S. Food and Drug Administration's (FDA) approval for its VASCADE MVP® XL venous vascular closure system. This significant advancement now allows the system to be utilized with procedural sheaths featuring an inner diameter (ID) ranging from 10 to 14F and an outer diameter (OD) of up to 17F. The updated labeling is particularly noteworthy as it means the VASCADE MVP XL system can be used with leading-edge technologies designed for pulsed field ablation (PFA) and left atrial appendage closure (LAAC), which are crucial in the management of atrial fibrillation.
This milestone was made possible by the AMBULATE EXPAND trial, a multicenter, prospective, single-arm pivotal study that evaluated the safety and effectiveness of the system utilized with 17F maximum OD procedural sheaths. Conducted at eight U.S. centers, the trial included 77 patients and reported impressive findings: no major or minor complications were related to access site closure, and patients had a median time to ambulation of just 2.4 hours. These results highlight the efficacy and safety of using the VASCADE MVP XL in more complex medical scenarios, demonstrating its capability to support modern medical practices.
The VASCADE MVP XL system is equipped with a 25F diameter disc constructed from resorbable, thrombogenic collagen, making it a unique option in the current market as it has been clinically validated for electrophysiology procedures using larger 17F procedural sheaths. Notably, the system simplifies the closure process for healthcare providers since it eliminates the need to downsize procedural sheaths to a smaller diameter, reducing potential delays in patient care.
Ken Crowley, the Vice President and General Manager of Interventional Technologies at Haemonetics, expressed enthusiasm regarding the FDA’s approval. He stated, "VASCADE MVP XL has emerged as the preferred device for advanced vascular closure, offering distinct clinical benefits and economic efficiencies for healthcare providers. With the newly approved expanded labeling for rapidly growing PFA and LAAC technologies, we are accelerating our commercial strategy and enhancing the number of procedures we can support across hospitals and ambulatory surgical centers in the U.S."
Haemonetics continues to pave the way in healthcare innovation with its full portfolio of vascular closure systems. The VASCADE MVP XL complements the complete range of VASCADE products, which include the original VASCADE system aimed at "small-bore" femoral arterial and venous closure and the VASCADE MVP® designated for "mid-bore" multi-access femoral venous closure. Each product is designed with a unique collapsible disc technology and utilizes a proprietary resorbable collagen patch that promotes rapid hemostasis during interventional procedures.
The continued success and innovation seen in Haemonetics’ products reflect the company's commitment to improving healthcare quality, efficacy, and efficiency. By addressing critical medical requirements, Haemonetics strives to enhance care standards and patient outcomes. To explore more about Haemonetics and its offerings, visit their official website at www.haemonetics.com.
As Haemonetics moves forward with its innovative solutions, it acknowledges the importance of proactive communication with stakeholders regarding forward-looking statements. Such statements encompass predictions about possible outcomes linked to product enhancements, reflecting the potential benefits of expanded labeling for the VASCADE MVP XL system. However, these statements are inherently uncertain and require careful consideration of various factors, including product quality and market dynamics. Haemonetics remains committed to updating its stakeholders as necessary based on these evaluations.
This milestone was made possible by the AMBULATE EXPAND trial, a multicenter, prospective, single-arm pivotal study that evaluated the safety and effectiveness of the system utilized with 17F maximum OD procedural sheaths. Conducted at eight U.S. centers, the trial included 77 patients and reported impressive findings: no major or minor complications were related to access site closure, and patients had a median time to ambulation of just 2.4 hours. These results highlight the efficacy and safety of using the VASCADE MVP XL in more complex medical scenarios, demonstrating its capability to support modern medical practices.
The VASCADE MVP XL system is equipped with a 25F diameter disc constructed from resorbable, thrombogenic collagen, making it a unique option in the current market as it has been clinically validated for electrophysiology procedures using larger 17F procedural sheaths. Notably, the system simplifies the closure process for healthcare providers since it eliminates the need to downsize procedural sheaths to a smaller diameter, reducing potential delays in patient care.
Ken Crowley, the Vice President and General Manager of Interventional Technologies at Haemonetics, expressed enthusiasm regarding the FDA’s approval. He stated, "VASCADE MVP XL has emerged as the preferred device for advanced vascular closure, offering distinct clinical benefits and economic efficiencies for healthcare providers. With the newly approved expanded labeling for rapidly growing PFA and LAAC technologies, we are accelerating our commercial strategy and enhancing the number of procedures we can support across hospitals and ambulatory surgical centers in the U.S."
Haemonetics continues to pave the way in healthcare innovation with its full portfolio of vascular closure systems. The VASCADE MVP XL complements the complete range of VASCADE products, which include the original VASCADE system aimed at "small-bore" femoral arterial and venous closure and the VASCADE MVP® designated for "mid-bore" multi-access femoral venous closure. Each product is designed with a unique collapsible disc technology and utilizes a proprietary resorbable collagen patch that promotes rapid hemostasis during interventional procedures.
The continued success and innovation seen in Haemonetics’ products reflect the company's commitment to improving healthcare quality, efficacy, and efficiency. By addressing critical medical requirements, Haemonetics strives to enhance care standards and patient outcomes. To explore more about Haemonetics and its offerings, visit their official website at www.haemonetics.com.
As Haemonetics moves forward with its innovative solutions, it acknowledges the importance of proactive communication with stakeholders regarding forward-looking statements. Such statements encompass predictions about possible outcomes linked to product enhancements, reflecting the potential benefits of expanded labeling for the VASCADE MVP XL system. However, these statements are inherently uncertain and require careful consideration of various factors, including product quality and market dynamics. Haemonetics remains committed to updating its stakeholders as necessary based on these evaluations.
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