1. What is VacuLink?

VacuLink is a single use vacuum measuring device which interfaces between vacuum extractors and the bedside maternal/fetal monitor to electronically measure the vacuum applied to the fetal head during a vacuum assisted delivery.

2. Has VacuLink been approved by the FDA?

In April of 2005, Medevco received FDA clearance to market VacuLink.

3. What training is required to use VacuLink?

VacuLink is very simple to use. There is an 8 minute training video here or Medevco’s local representative can provide you with a CD ROM version of the video for training purposes and a representative is also available to demonstrate VacuLink at your hospital.

4. How long does it take to connect VacuLink?

It requires approximately 60 seconds to open and connect VacuLink to the maternal/fetal monitor and the handheld vacuum extractor.

5. Which maternal/fetal monitors are compatible with VacuLink?

VacuLink is compatible with GE (Corometrics) and Philips (HP) monitors.

6. Which handheld vacuum extractors are compatible with VacuLink?

Clinical Innovations has adapted both the Kiwi Omnicup and ProCup models to interface with VacuLink, and those devices are available now. Through use of a “T” adaptor, VacuLink interfaces with the Mityvac reusable vacuum pump. Medevco has been informed by CooperSurgical that the single use Mystic vacuum device is being modified for VacuLink connection and will be available by late 2006.

7. What is Medevco?

Medevco is a privately held company in Dallas, Texas that has developed VacuLink. Medevco is currently concentrating its efforts on marketing VacuLink, but expects to develop other medical devices in the future.

8. Are there patents on VacuLink?

Currently there are 4 patents issued by the United States Patent Office (insert link to our patent page on the website.)In addition, two more patents have been applied for and are under review. Medevco also has patents for VacuLink in Western Europe, Israel, Korea, Brazil, Canada, Mexico, Japan and other countries recognizing patent law.

9. When did VacuLink sales commence?

VacuLink sales began in late 2005.

10. Who are the local distributors?

US distributors for VacuLink are:

• Pacific Northwest: (Oregon and Washington). Paradigm Medical Systems: 888.214.9217
• Southwest: (California, Nevada, Arizona, New Mexico, Rocky Mountains, Oklahoma, Texas, Hawaii and Alaska). Kentec Medical: 800.825.5996
• Upper Midwest: (Dakotas, Minnesota, Northern Wisconsin and Upper Peninsula of Michigan). Master Medical: 651.695.2316
• Ohio Valley: (West Virginia, Kentucky and Indiana). Expanding Medical Technologies: 888.790.3681
• North Central: (Ohio, Western Pennsylvania and Michigan’s lower peninsula). Innovative Medical Systems: 616.735.0200
• East Coast and Southeast (Maine, New Hampshire, Vermont, Rhode Island, Connecticut, New York, New Jersey, Eastern Pennsylvania, Delaware, Maryland, Washington, DC, Virginia, Carolinas, Georgia, Florida, Alabama. Mississippi, Louisiana, Arkansas, and Tennessee). KOL Bio Medical Instruments: 800.336.5018
• Midwest: Contact Medevco directly at 972.788.4372

11. How much does the VacuLink cost?

Check with your local distributor for complete pricing.

12. Has VacuLink been used in court at this point?

VacuLink has not been used in a court case yet.

13. How does Medevco envision VacuLink would be used in a court case?

One of Medevco’s board members is the chairman of the health law group of his large Dallas law firm. From his many experiences defending lawsuits related to vacuum-related injuries, he believes it will be of great assistance to the defendant hospital(s) and physician(s) who use vacuum within the standard of care but are still named in medical malpractice claims because of an adverse outcome.

Opinion of Victor L. Vines, M.D. (Inventor, Founder of Medevco)

14. Does Medevco see VacuLink being of greater help to the physician and defense attorneys or to the plaintiff’s attorneys?

Opinion of Victor L. Vines, M.D. (Inventor, Founder of Medevco)

We anticipate that incorrectly performed vacuum deliveries will be substantially less likely to occur when electronic monitoring is in place, thus the net benefit accrues to the patients, and decreases exposure to the hospitals and physicians. David Marchand, a plaintiff’s lawyer in Dallas, Texas wrote about VacuLink and stated that “In reviewing a potential case involving an infant whose injury was allegedly associated with a vacuum assisted delivery, I would look to the medical record for evidence that the use of vacuum was beneath the standard of care. If the record contained a VacuLink tracing showing that the guidelines for vacuum use were appropriately followed, that would be strong evidence against pursuing a case on that basis.” As an expert in over 100 medical malpractice cases, it is my personal experience that when the objective evidence demonstrates that the physician complied with the standard of care, there is no negligence, regardless of the outcome. We at Medevco sincerely believe that objective, real-time documentation of vacuum events will result in better communication, better decisions, and improved patient outcomes.