New information regarding Protime Unit and Home Testing

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Well-known member
Jun 11, 2001
Hi Everyone,

I just found this information and thought I would share it with you. The articles will also provide you with additional information which may help you that are having trouble convincing your doctors to allow you to get one, additional information that may change their minds.

QAS.. .. Does this first article impact your business?

Happy Holidays,

ps... Thank you Cardio-Star for originally posting this on WebMD


Sulzer Carbomedics Inc.

Austin, Texas

December 3, 2002


Sulzer Carbomedics Inc. (Carbomedics), a subsidiary of Centerpulse Ltd and a world leader in products for treatment of valvular heart disease (VHD) announces an agreement with Thoratec's International Technidyne Division (ITC) to co-market ITC's ProTime Microcoagulation System to cardiologists and cardiovascular surgeons.

ITC's ProTime system is the only prothrombin time INR monitor currently available for physician office lab and home testing. (¹See info about HemoSense's INRatio Self-Test PT Monitoring System below)

Previously, reimbursement for anticoagulation testing was available only when the procedure was conducted at a doctor's office or lab.

HOWEVER, Medicare recently announced that coverage has been expanded to include home testing for Medicare eligible mechanical heart valve patients.

Over 1.8 million patients in the U.S. use an oral anticoagulant medication, Coumadin® (warfarin) to reduce their risk of life-threatening complications.

Of this 1.8 million, approximately 400,000 patients are under life-long warfarin management for mechanical heart valve implantation, with close to 250,000 patients Medicare eligible.

- Home Home on the "range" -

----?When drug levels are outside of therapeutic range (narrow therapeutic index), the risk of complications rise.

The ITC ProTime system allows patients to monitor their blood's clotting activity in the privacy of their homes.

----?Studies have shown that patients who test more frequently (i.e., at least weekly) experience up to 70% FEWER life-threatening complications than those who do not.

Self-testing at home allows these patients to test with this frequency.

"Clinical findings indicate that the Carbomedics Prosthetic Heart Valve provides the lowest rates of thromboembolic complications among leading mechanical heart valves."
stated John Groover, President of Carbomedics.

"With better patient management of anticoagulants complication rates SHOULD BE EVEN LOWER.

This will translate into optimal hospital and physician utilization, better patient outcomes, and lower health care costs.

We are excited about co-marketing ITC's ProTime system which provides an innovative solution to meet the needs of both the cardiovascular community and patients who take anticoagulation medication."

"The ProTime System is an easy-to-use device that requires minimal training and provides accurate measurements.

It is ideal for the home user with its virtually pain-free blood collection system and easy-to-use meter."stated Lawrence Cohen, President of ITC.

Under terms of the co-marketing agreement, Carbomedics' sales representatives will promote the ProTime Microcoagulation system to cardiovascular surgeons who implant prosthetic heart valves.

ITC's sales force will promote the use of Carbomedics' prosthetic heart valves to cardiologists.

About Carbomedics

Carbomedics has manufactured prosthetic heart valves since 1969 and has marketed its mechanical valve products internationally since 1986 and in the United States since 1993.

ITC's ProTime Microcoagulation System has been approved for use since 1995.

Centerpulse, headquartered in Zurich, Switzerland, develops, produces, and distributes medical technology implants and biological materials for orthopedic and cardiovascular markets worldwide.

The product array includes artificial joints, dental implants, spinal implants and instrumentation, trauma products, and heart valves.


For mechanical heart valve patients visit:

Valve Replacement com

See Forums

The ProTime Microcoagulation System


Home address:



HemoSense INRatio Self-Test PT Monitoring System

Posted 11/13/02

HemoSense, Inc.

HemoSense Announces FDA Clearance of the INRatio Blood Coagulation Testing Sytem for Patient Home Use

Milpitas, California

November 5, 2002


HemoSense, Inc. announced [today] that its INRatio Self-Test PT Monitoring System ("INRatio") received Food and Drug Administration (FDA) clearance for use by patients in the home by prescription.

INRatio represents a NEW GENERATION of portable, handheld analyzers that test and record the clotting time of blood via Prothrombin Time (PT) testing.

The Company's product consists of a low-cost meter and disposable test strips geared for patient use at home and for use by medical professionals in a physician's office or clinical setting.

"INRatio's clearance by the FDA, coupled with the recent reimbursement ruling by Medicare, represents an important validation of the product and market opportunity," said Jim Merselis, President and CEO of HemoSense.

"Moreover, this important milestone clears the way for INRatio's market introduction."

---?More than 6 million (WOW!) people worldwide are treated with oral anticoagulants (Coumadin®) for a variety of clinical conditions.



These conditions, called thrombotic disorders, result in the unwanted formation of a blood clot or "thrombus."

Oral anticoagulants decrease the clotting ability of the blood, minimizing the occurance of blood clots (a primary cause of brain attacks).

The routine measurement of Prothrombin Time is a test performed to control the safe and effective management of oral anticoagulation therapy.

Through the use of "self-test" monitoring systems in their home by prescription, studies have shown patients have better therapeutic control and reduce cost.

About HemoSense, Inc.

Based in Milpitas, Calif., HemoSense was founded in 1997.

INRatio is based on the Company's proprietary electrochemical detection technology that combines principles of classical electrochemistry and modern sensor technologies.

These enabling technologies provide a highly sensitive way to directly monitor the coagulation clotting process using a very small blood sample.

----?INRatio has eliminated the need for complex and costly optical detection systems found in other systems.

INRatio is the FIRST product that applies HemoSense technology to assist healthcare professionals and patients manage oral anticoagulation therapy.

HemoSense was founded by Arvind Jina, Ph.D. to commercialize his patented technologies for monitoring blood coagulation.

Prothrombin Time Testing Made Simple

Patients taking oral anticoagulation medications such as Coumadin® (warfarin) can now monitor the clotting time of their blood with fewer steps using the hand-held INRatio? meter.

On-board quality controls and a simplified test procedure provide fast, accurate, and reliable results, saving time and cost both for patient and professional.

Bringing the Lab to the Patient

HemoSense? is empowering patients to be more involved in their oral anticoagulant therapy using next generation technology.


ALSO see:

ITC ProTime®

Microcoagulation System

Now approved for Medicare reimbursement

DIRECT address:


CoaguChek? System



WebMD Article Archives

At-Home Monitoring Works for People on Blood Thinners

Technique Found to Be Safe and Effective

By Roxanne Nelson, RN

Reviewed by Michael Smith M.D.

July 6, 2000


People who take [so called] blood-thinning medications to prevent clots (thrombosis) may be able to safely skip some of those repeated trips to the doctor to have their blood checked.

A new study finds that patients who monitor their own blood-clotting time and drug dosing at home do just as well as those who have it done by a doctor or lab.

In a study published in the medical journal The Lancet, Dutch researchers found there was virtually no difference between patients who managed their own care at home and those who had it done at a clinic.

In some ways, the patients who monitored themselves at home did better than the ones seen at a clinic, and most of them preferred self-treatment.

The most common blood thinner is called Coumadin® (warfarin) , and it is taken to prevent blood clots in patients at risk for having a brain attack (stroke), heart attack (myocardial infarction), or blood clot in the leg (Deep vein thrombosis a.k.a. DVT) or other part of the body.

People taking Coumadin® usually go to the doctor to have blood drawn to test their blood's clotting time every few weeks to make sure they are taking the correct dose of medicine.

Taking too much Coumadin® increases the risk of excessive bleeding, and too little medicine does not protect against clots.

Home management of blood-thinner therapy may give patients more control over their treatment and result in improved compliance in taking the Coumadin®, according to study author Manon Cromheecke, M.D., of the department of cardiopulmonary surgery at the University of Amsterdam in the Netherlands, and colleagues.

The researchers theorized that since easy and reliable monitoring devices have become available for home use, this might allow patients to take a more active role in their care.

They divided 50 patients into two groups. One group monitored their blood levels at home and made their own adjustments in their medication, while the other group had the monitoring done at a specialized clinic.

At the end of three months, the groups switched places.

The patients who had received care at the clinic now monitored their blood at home, and vice versa.

No significant differences were found between the two groups; in fact, patients appeared to do a little better when they were self-monitoring.

Their blood-clotting times were more consistently in the best range for keeping both clotting and bleeding under control.

Julie Hambleton, M.D., compares self-management of blood thinners to the way diabetics manage their blood-sugar levels:

"Diabetics have much tighter control, since they can monitor themselves at home, they're not going to come into a clinic four times a day, so the same aspects may apply to Coumadin® therapy."

Hambleton, who was not involved in the study, is director of the Hemostasis and Thrombosis Center (HTC) at the University of California, San Francisco (UCSF).

She says some of her own patients on blood thinners do self-monitoring.

"Patients can safely self-manage and then, like a diabetic, have some guidelines as to when to call in.

That's actually how I do it with some of my own patients who have home monitors.

They don't call me if they are in the right range, and I have them keep a diary so we can keep track of trends."

On a quality-of-life (QoL) questionnaire, the study participants also indicated that they were more satisfied with doing their own self-management.

----?And they reported less stress and anxiety when managing themselves than when they were managed by the clinic.

The researchers believe that self-management with blood thinners may be at least as effective as management by a specialized clinic.

Self-management, they say, "may be considered as a novel, patient-friendly, and effective strategy to improve long-term treatment with anticoagulant agents."

"This type of study is important for us as [doctors], because it shows that this is very feasible as well as cost saving," Hambleton says.

"For example, for Medicare, they would have to pay up-front costs for the monitoring device, but they would save in the long run because patients would only need to go to a clinic three or four times a year, and they'd have much better control."




Many thanks for reading this message.



Global Alliance

We Care


C~]::::::::::::?Fighting heart disease and brain attack world-wide

A stroke is a BRAIN ATTACK!

Don't let a stroke blow your mind.


Hello Rob,

We feel that the greater marketing and reps in the physicians office will be a great asset to our company. The marketing agreement in your post will be a way to get the word out regarding the ProTime Monitor. We have been doing this since 1997, and were the only company in the United States to specialize specifically in fingerstick testing of INR. Remember a month or so ago when people thought that there should be more done to market this device? Well, now we see that there is significant progress being made. In regards to the FDA approval of that new device, I feel that it will make our business even better. Do you remember when Avocet came out? Well, as it turns out, companies that enter the market and really promot there device end up assisting the other monitors out there. Most buyers are educated enough to look around before making there decisions. This will only benefit ITC and Q.A. Services. We do our part to market and get people educated about ProTime, but we are not a billion dollar company with unlimited resources. One day there may be 20 different coagultion meters, and we are one of the pioneers. I think that speaks for the job that we have done so far, and we will do everything to keep improving and assisting patient's. Have a good holiday!

Howdy Rob,

Hope your warmer than I am :D

Thanks for the info! Lance does have a point. If I were in the market for such a 'crutial' device. I would go with the tried and true. With the Protime and the Coaguchek being the only units that are widly used. New man on the block would have to prove himslef before I would even consider it. Same thing with a new drug or any other medical device.

We have to rememebr just because it "FDA" approved. Does not mean it is safe. We have seen unfortunate examples of that right here.
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