Not all 7Fr catheters are alike. So Insightra Medical has put together a simple page to explain why the ULTRA 7Fr technology is absolutely unique:

TRUE 7Fr
From the soft distal tip of the catheter, to the wrapped balloon, to the transition between the balloon and the catheter body and the entire length of the catheter body are ALL 7fr. This means that our catheter can pass through any manufacturers 7Fr sheath. It's a True 7Fr from tip to tail. And that ensures it's the smallest adult IAB catheter available today.

7Fr size yet 8Fr Performance
Anyone can make a catheter small, but not all companies can maintain a high gas flow. Our engineers in Japan were determined to reduce the catheter size, without compromising gas flow. Through a complete redesign of the catheter and advanced engineering techniques they managed just that. Inflation and deflation speeds are comparable to equivalent volume 8Fr catheters - not an easy thing to do. And that holds true not just for new hardware, but also old hardware. Insightra and Independent bench top testing have shown no loss of performance with the 7Fr balloon. Independent clinical studies have shown that clinical outcomes are equivalent to competitive 8Fr catheters. Even in patients with arythmias and tachycardia.

Making a 7Fr catheter is one thing - preserving gas flow speeds of an 8Fr is another!

Maintaining Balloon Reliability
One of the hardest parts of getting an IAB catheter to be 7Fr along its entire length is having the wrapped balloon portion to also be 7Fr. One solution is to make a thinner balloon so it wraps down tighter. At Insightra we don't compromise on balloon thickness - our 7Fr Balloon is the same design as our 8Fr balloon. Bench top tests (data on file) show that our 7Fr balloon is just as resistant to abrasion as other 8Fr balloons. Yet the engineers in Japan through advanced, proprietary wrapping technology can take a full thickness balloon and get it wrapped down to 7Fr.

Quality Above All Else
Probably the most critical aspect of any IAB Catheter is the quality of construction and the degree of testing. All of our balloon catheters are made by our partner TMP of Japan. Every catheter is meticulously hand assembled and then every catheter is placed in a pressurized test rig and tested for 12 hours - or 50,000 cycles. This is to ensure that every catheter which leaves the factory has passed the most rigorous testing in the industry. The first inflation inside the patient is number 50,001 for the catheter.

Widest Range of 7Fr Catheters
Not all populations are the same, not all patients are the same - that's why Insightra medical provides the widest range of 7FR catheter balloon volumes. Sizing really matters. Mismatching of balloon size to the aorta is the number one reason for abrasions of Intra Aortic balloon membranes. We at Insightra ensure that no matter what the height of the patient, or limited length of plaque free aorta - there is a balloon to meet that patients needs. 40cc, 35cc, 30cc, 25cc and 20cc are available all on a True 7Fr shaft. In certain populations such as India, over 60% of the population are best served by a 35cc balloon - not a 40cc. So we allow the best matching of balloon length to the patient population. This is critical in high risk populations such as short women with PVD and diabetes - correct balloon sizing and smallest catheter body are the best combination for these patients.

Heritage and Data
Insightra Medical and TMP have spent years perfecting their IAB technology, and years testing it. The 7Fr IAB technology at the heart of the Insightra catheter kit has 10 years of heritage and clinical usage. With over 40,000 implants world-wide, we have one of the lowest complaint rates in the industry. We are happy to share each and every product complaint with clinicians - to demonstrate our commitment to quality, our low complaint rates and our world-class post market follow up of our products.

Universal Compatibility
Insightra's IAB catheters are compatible with the two leading pump manufacture's hardware. Insightra is obligated to test the compatibility of our catheters on each model of pump that we say it can be used with. We have demonstrated in bench top testing, our own clinical testing and independent clinical testing all aspects of the function for safety and effectiveness of our IAB catheters. We have tested with a wide range of old and new pumps, for inflation deflation speeds, alarms, leak testing and all aspects of the balloon usage. This is the obligation of Insightra Medical, not the pump manufacturers - and we have passed those tests with flying colors to obtain approvals by the FDA, CE authorities, Canadian FDA, Japanese authorities, Indian FDA, and many other regulatory authorities.

One of the key factors enabling Insightra to have this broad range of compatibility is for us to retain tried and tested fluid filled technology pressure monitoring. This eliminated the need for exclusive fiber optic hardware, meaning 7Fr technology for all patients without the costs of upgrading.