Patient Characteristics and Outcomes Similar to Standard of Care

In patients undergoing peripheral vascular interventions (PVIs), a minimally invasive procedure that restores blood flow to the lower extremities, safety and efficacy following use of the VASCADE closure device (VCD) was comparable to the standard treatment option for patients with severe peripheral artery disease (PAD), finds a new Yale-led study.

In this one-center retrospective review, 200 patients were identified at Yale New Haven Hospital. The overall aim of this study was to evaluate the safety and efficacy of the VCD compared to manual compression (MC) in higher-risk patients undergoing endovascular procedures between 2018 and 2020.

The results are published in the journal Catheterization and Cardiovascular Interventions.

Cardiva Medical’s vascular closure was approved by the US Food and Drug Administration in January 2013. The VASCADE closure uses an extravascular collagen plug to stop bleeding more efficiently than manual compression alone. The researchers found that the 30-day death rates were similar between the two patient groups. They also found that there were no differences in minor or major complications after 30 days.

First author is Sameer Nagpal MD, assistant professor of medicine.

Senior author is Carlos Mena-Hurtado, MD, associate professor of medicine.

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Other authors of the study are Lindsey E. Scierka, Yulanka Castro-Dominguez, Dhruv Kansal, Steffne Kunnirickal, Yasin Hussain, Keith Love, Edouard Aboian and Kim G. Smolderen.

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The research is supported by Cardiva Medical. Smolderen receives research grants from Cook Medical, Merck & Co, Shockwave Medical and Johnson & Johnson. Mena-Hurtado has received support from Shockwave Medical.

Submitted by Elisabeth Reitman on September 21, 2022

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