Claret Medical ropes in $18M to develop cerebral protection system for TAVR procedures

Claret Medical's Sentinel System--Courtesy of Claret Medical

Claret Medical roped in $18 million in Series B financing to support development of its cerebral protection system for transcatheter aortic valve replacement (TAVR).

The Santa Rosa, CA-based company will use funds to complete a pivotal U.S. trial of its Sentinel Cerebral Protection System, a device that collects and removes dangerous debris during TAVR procedures. Claret Medical won Investigational Device Exemption and a CE mark for its product earlier this year, and plans on launching two other studies of its Sentinel system for structural heart procedures, the company said in a statement.

Venture capital firm Santé Ventures led the round, with Lightstone Ventures and Easton Capital contributing additional funding.

"Many consider the stroke rate in TAVR concerning, especially as clinicians look to bring the benefits of TAVR to lower risk and younger patients," CEO Azin Parhizgar said in a statement. "The proceeds of this financing round will enable Claret Medical to conduct the SENTINEL pivotal trial, which we expect to confirm the therapeutic importance of embolic debris capture and removal during TAVR."

A fresh infusion of cash bodes well for Claret Medical, as the company continues to build its offerings and develop new cardiac products. Last July, Claret reeled in $3.6 million of an envisioned $4 million venture financing round to advance its Montage dual filter system for intravascular procedures. The company secured a CE mark for a next-generation version of the device in 2011.

Meanwhile, big names like Boston Scientific ($BSX), Medtronic ($MDT) and Edwards Lifesciences ($EW) are vying for a top spot in the TAVR playing field. In June, Medtronic won expanded FDA approval for its transcatheter heart valve for patients with severe aortic stenosis who are too frail for traditional surgical valve replacement. Days later, Edwards got a regulatory green light for a U.S. rollout of its Sapien XT device, a rival product that treats high-risk and inoperable patients. Not to be outdone, Boston Scientific won expanded European approval for its Lotus transcatheter valve system in July, strengthening its foothold in overseas markets and paving the way for full FDA approval of its product.

- read the release
- here's MassDevice's take

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