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Clinica's MedTech Ventures: Claret Medical

This article was originally published in Clinica

Executive Summary

Specialty area(s): Protecting brain during transcatheter aortic valve replacement
Based in: Santa Rosa, California
Founded in: 2009
No. of employees: 25
Total investment received to date: $13m
Investors: Private investors

The transcatheter aortic valve implantation (TAVI) market is one of the medtech success stories of recent years, seeing year-on-year growth of around 15-20%. But with TAVI comes the risk of stroke, as debris can be dislodged and travel to the brain, where it can cause blockages.
The PARTNER study, used as the basis for US FDA approval of Edwards Lifesciences’ market-leading TAVI device Sapien, found link between the procedure and a stroke rate of 4-7%, “depending on the risk profile of the patients.” That is according to Tony Fields, chief operating officer of Claret Medical, a company that has developed a device to address the problem of stroke during TAVI.
The product, called the Sentinel Cerebral Protection System, is a percutaneously delivered device with two filters that are placed in the key vessels leading to the brain, which capture and remove debris dislodged during endovascular procedures. It is placed before the TAVI procedure then removed from the patient afterwards, along with the captured debris. “Currently we capture debris 75-100% of the time,” the COO said. “Everyone’s really curious to see what they captured and what size the debris is.”
Of all the strokes linked with TAVI, more than 50% of these occur during or immediately after the procedure, Mr Fields estimates – this is the population that Claret is targeting. He believes all patients should receive the Sentinel, not just those at high risk of stroke. “It’s like putting on your seatbelt in a car – I’ve never had a car crash, but obviously people die in car crashes. I see no reason to stratify patients based on risk since the conventional risk scores do not consider the degree of vascular and valvular atherosclerosis, and almost all TAVI patients have tremendous atherosclerotic burden.”
Santa Rosa, California-based Claret CE marked its first-generation Montage device in October 2011 and has been selling in Europe for almost two years through distributors. Since then, it has also CE marked the next-generation Montage 2 (in February 2013) and Sentinel (in December 2013).
Although he was reluctant to say how much the device costs, Mr Fields stressed it is a fraction of the entire TAVI procedure – probably around 5%, he estimated. The process is also quick, with the device taking around 3-4 minutes to put in. “So from a procedural time and cost standpoint it’s quite small.”
The company is planning to start a US pivotal study of Sentinel within the next three months, having received IDE approval from the FDA in February. The trial will look at differences in brain lesions between a control group and treated group, using diffusion-weighted MRI. This is a surrogate marker for stroke that has been agreed with the FDA – showing a difference in the incidence of stroke itself would require a much larger study than a small company like Claret would be able to carry out, Mr Fields explained.
The COO added it was “hard to say” when the trial would finish and when Claret would be able to file for FDA clearance. However, the company has already started thinking about reimbursement. “We’ve designed our US study to be sufficiently big to convince the reimbursement agency CMS as well.”
Could the device save healthcare systems money? “I think there are two very strong arguments in favor of our device. One is the ethical cost of trying to prevent stroke, and obviously the financial costs to healthcare systems of stroke are very high. I’m sure we’ll be able to show that eventually [we can reduce overall costs], as the use of embolic protection devices has been shown to do in carotid artery stenting.”
The firm is currently in the midst of a fundraising effort to add to the $13m it has already raised from private investors – but Mr Fields declined to say how much it is looking for.
He believes the market for Claret will be worth around $200m by 2017 for the TAVI sector alone. But the device could also be used in other procedures, “such as surgical valve replacement, which has a 3% stroke rate” as well as other structural heart procedures, the COO said.
But how will uptake be, bearing in mind that clinicians have now been carrying out TAVI and other procedures without devices such as Sentinel for some time? “I personally wouldn’t let any relative of mine have a TAVR procedure without it, independent of age or risk,” said Mr Fields.
He doesn’t believe that any other companies are developing a similar filter, but there are two “deflector” devices that are also CE marked but do not have an approved IDE with the FDA or FDA clearance: the Embrella Embolic Deflector developed by Embrella Cardiovascular, which was acquired by Edwards for $43m in 2011; and the TriGuard Device, developed by Israeli company Keystone Heart.
However, Claret’s filter has an advantage over the deflectors, said Mr Fields. The latter deflect debris downstream, rather than removing it completely. “That debris is terrible in your brain, but it’s not so great in your kidneys either – it’s going to go somewhere else.”
So are the big cardiovascular players, such as the aforementioned Edwards, as well as Medtronic, St Jude Medical and Boston Scientific, keeping an eye on Claret? “We’ve certainly been in discussions with all of them, they’re aware of us.”
But they are likely keeping their cards close to their chest until results from Claret’s US study are in. “They would be happy to not need our product, but as soon as it’s shown that they need it, they’ll want it,” Mr Fields said.
He added that Claret’s technology could aid these TAVI players as they try to expand approval to include lower-risk patients. “I’m sure they’re as interested as we are in preventing procedural strokes, and I think that’s going to become even more important. The initial approvals for TAVI devices were for non-operable patients. Now companies are starting to do studies to push that indication to younger and younger patients. So their goal, clearly, is to try to move to healthier and healthier patients where, our feeling is, the [impact] of stroke is so much higher.”
Tony Fields, chief operating officer.
Tel: +1 707 528 9300
Email:
tfields@claretmedical.com
Claret Medical, Inc., 1745 Copperhill Parkway, Suite 1, Santa Rosa, CA 95403, US.
www.claretmedical.com

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