Ovix Eclipse | Mysite 1

ECLIPSE OCCLUDER

Ovix Eclipse is a revolutionary vaginal occluder designed to:

• improve patient safety and outcomes

• be quickly utilized in surgical settings

• decrease hospital and physician liability

OVIX ECLIPSE SOLUTION

In the United States there are over 600,000 hysterectomies performed each year. During this procedure the uterus is normally removed through the vaginal canal. Currently there is no instrument available to maintain pneumoperitoneum following extraction. Makeshift devices are constructed of various items, none of which have the intended use of occluding the vaginal canal. The Ovix Eclipse is designed to safely provide the necessary occlusion.

• Current Regulatory status:

• US Patent #8,562,623

• FDA Class II Device

• Submitted Pre-submission to FDA and received feedback

• Regulatory pathway 510K submission

Experienced and knowledgeable

contractors utilized to date: Astute, In2being, Medbio

DEVICE HISTORY

The Ovix Eclipse vaginal occluder was designed by Ross McDonald, CSFA, a Navy veteran with over 15 years of surgical experience. During his time in the OR, Ross observed the failings of the commonly used, field-expedient methods of maintaining pneumoperitoneum after laparoscopic total hysterectomy, using items such as a ring forceps, a glove, and laparotomy sponge. Recognizing the physical and financial risks to both the patient and hospital inherent in the use of these makeshift devices, he created a safer and more effective solution.

Ross McDonald, Laura McDonald

480 670-4534

ross@ovixsurgical.com