Because of the ease of insertion, the FirmGrip will also ease the burden on patients who require an IV for fewer than 20 days and will spare them the discomfort of having to have a new IV inserted (in a different vein) every three days. If you’ve been admitted to the hospital this year, there’s a good chance you’re one of the 42.5 million Americans who have received an intravenous (IV) catheterization.
And there’s an additional 70% chance that your IV – done through a peripheral IV line – was administered for longer than three days, which required the catheter that was inserted to be replaced in order to prevent inflammation.
A peripheral IV line consists of a short catheter (a few centimeters long) inserted through the skin into a peripheral vein. A peripheral vein is any vein that is not in the chest or abdomen. Part of the catheter remains outside the skin, with a hub that can be connected to a syringe or an intravenous infusion line, or capped with a bung between treatments. The caliber of cannula – or the tube that enters the body – is commonly indicated in gauge, with 14 being a very large cannula (used in resuscitation settings) and 24-26 the smallest.
The discomfort faced by patients at changing the cannula is matched by other problems – the dangers faced of infection as well as the difficulty in older patients in finding healthy veins, according to Shai Amisar, a medicinal chemist who is chief technical officer of Flexicath, a young Israeli startup.
“Since many of the patients are over 55, and have already received many treatments, there’s a good chance they have bad veins, not to mention high blood pressure, obesity, diabetes, or other complications,” he told ISRAEL21c. “For these people, it’s not simple to insert an IV line, and nearly impossible to insert a second one in three days or a third one in six.”
Today, inserting an IV catheter that can remain in place for longer than three days requires what is tantamount to a surgical procedure. Flexicath has solved that problem by developing an IV catheter – the FirmGrip – that can be left in place for up to 20 days.
According to Amisar, the vast majority of patients receiving IV therapy require treatment for periods of longer than three days. “Most IV treatment is to transmit antibiotics – which usually need to be given between seven and 12 days,” he said.
Flexicath’s product shortens the procedure, cuts the cost, and allows any member of the medical team – paramedics, nurses, and of course physicians – to insert it. Because of the ease of insertion, the FirmGrip will also ease the burden on patients who require an IV for fewer than 20 days and will spare them the discomfort of having to have a new IV inserted (in a different vein) every three days.
Flexicath is beginning safety trials of the FirmGrip next month at Meir Hospital in Kfar Sava under the supervision of the head of the hospital’s internal medicine Dr. Yitzhal Brenner. According to Amisar, one of the largest pharmaceutical companies in Israel is co-funding the trial, due to the interest it has shown in the device.
“The trials are to check the safety aspects and to make sure there’s no problems that arise when you leave the canula in the vein,” he said.
Flexicath was founded in 2004 by Amisar and his partner (and the company’s CEO) Ronen Radomski, together with Professor Paul Froom who devised the concept behind the Firmgrip.
“Ronen and myself had known each other for years, and served in the army together. I was a medic, not such a prestigious position,” Amisar said with a laugh.
“We met Professor Frum who came to us with the idea of inserting a catheter into an already existing cannula, which would remove the need to change the cannula every three days.”
Froom, who holds an MD from Creighton University in Nebraska, serves as director, of the master’s program in occupational health at Tel Aviv University Sackler Medical School and director of the Haifa and Western Galilee General Health Services hematology laboratory.
Once the concept was in place, the company was accepted to the Misgav Technology Center incubator program in northern Israel, where it was able to develop. Last year, it ‘graduated’ to independent status and completed a first round of capital mobilization, raising $350,000 from its former paretn Misgav and from the Trendlines Israel Fund.
According to Amisar, Flexicath is developing three variations of the FirmGrip.
** The main product combines a standard catheter enclosed in a polymer sleeve with a special silicone insertion unit to produce a self-contained sterile catheter insertion field.
** The FirmGrip 60 model adds a sterile sleeve to the standard peripheral insertion central catheter (PICC) which is used for long-term IV therapy. The insertion technique is the same as currently used for PICC/mid lines. The handgrip improves insertion control and the sterile sheath prevents contamination risk.
** The FirmGrip 15, in which a soft, “mini” midline catheter (15 cm) encased in the compact sterile sleeve is inserted using a peel-away insertion needle as a point of entry. Having the mini midline encased in the sterile sleeve reduces the chance of infection and the need for an external sterile environment. FirmGrip 15 provides physicians the flexibility to leave a soft catheter in place for treatment periods of up to 15 days.
Initially, Flexicath will sell complete “mini” midline and PICC line kits (with the FirmGrip .15 and .60) through partnerships with smaller manufacturers and distributors, and hopes to establish strategic alliances with major players in the IV catheter market.
Amisar expects to receive FDA approval for the Firmgrip by the end of the year and plans to begin marketing by February.
“We recently graduated from the incubator and are standing on our own. Things are going according to plan.”