Yokneam, Israel-based Rapid Medical has won the FDA's nod for its Comaneci device temporary coil embolization assist device. The company said that Comaneci is the first in a new category of temporary coil embolization assist devices.
The Comaneci is an adjustable, fully visible aneurysm remodeling device, which acts as a temporary bridge used to aid in the coiling processes while minimizing the risk of coil protrusion or prolapse. Upon the completion of the coiling procedure, the device is removed from the parent artery. It does not require parent vessel occlusion during coiling procedure or the need for long-term antiplatelet medication in case of permanent stenting.
Ronen Eckhouse, Rapid Medical's co-founder and CEO, told BioWorld MedTech that he thought that a company in the U.S. was trying to develop a similar device, but that it was nowhere close to getting to market. Eckhouse added that Comaneci should be available in about a month for initial evaluations.
"Feedback has been very positive," he added when asked about what he has heard from the field about the device. "The Comaneci is a very special device which bring unique benefits to patients and physicians. It has been used in about 3,000 procedures [outside] the U.S. so far." Comaneci has the CE mark and won this de novo nod late last month. The classification product code is PUU.
Peter Kim Nelson, professor in the Departments of Radiology and Neurosurgery in the New York University School of Medicine and chief of the Bernard and Irene Schwartz Interventional Neuroradiology Section within the NYU Langone Health system, expressed enthusiasm about having the device. "It should be a valuable alternative for ruptured and unruptured wide neck aneurysms, typically requiring balloon assistance for coil embolization, since it provides temporary protection of the parent artery during aneurysm coiling without arresting flow," Nelson added.
In addition, the device can help improve the patient and health care facility experience. "Oftentimes, using the Comaneci device can replace the use of a stent in the brain. As a result, the cost to the hospital will be lower, and the patient will not be required to take prolonged anti-platelet medication," Eckhouse explained. "This is especially critical for the treatment of aneurysm[s] [that] have already ruptured."
He also confirmed that the company is looking to other geographies for commercialization, such as Japan, China and Latin America. And there are future plans for the company in the U.S. "We are in the midst of clinical trial for our stroke device (Tigertriever) and also have other one-of-a-kind devices that we hope to clear in the U.S. soon," Eckhouse added.
In late April, the company reported that it had completed an oversubscribed series C financing of $20 million. The proceeds were earmarked to help in the completion of the Treatment with Intent to Generate Reperfusion (TIGER) U.S. IDE study, which began enrolling patients in May 2018, and to boost commercial growth of the company's minimally invasive stroke treatment and prevention products worldwide. The round was led by Jam Capital Partners and Microport with participation from Agate Jt, Rocson Medtech Fund and existing investors.
The multicenter TIGER study is assessing the performance of Tigertriever, the company's thrombectomy device for the acute treatment of ischemic stroke. It will support the company's 510(k) submission to the U.S. FDA to obtain clearance to market the device.
The company also noted that the proceeds would go toward building a commercial presence in the U.S. ahead of regulatory signoffs, as well as expanding Rapid Medical's sales and marketing efforts in Europe. In addition, the company will use the proceeds to the continued development of additional products.
For its part, Vancouver, British Columbia-based startup Evasc Neurovascular Enterprises ULC has developed the Eclips Aneurysm Remodeling System. In 2017, the company secured a $7.5 million series A financing that it said would go toward studies. (See BioWorld MedTech, June 16, 2017.) Evasc received a nod in Canada for use of Eclips under the Special Access Program in 2013, and received CE mark approval in 2015.
"The device came out of the need to retain coils in wide-neck terminal aneurysms that had a bifurcation. The need arose because in the early days and still to the present time clamping coils at a wide neck doesn't give enough of a rim at the neck to hold the neck in place, they need something to help retain them," Evasc co-founder and CEO Donald Ricci told BioWorld MedTech in 2017. He noted that the Eclips device was developed as a coil retaining device; however, the company determine it could serve as a flow diverting device and a platform for endothelial growth across the neck of the aneurysm.
In its latest news, the company reported last September that it had signed a distribution agreement with Logsa Endomedical for Spain and Portugal.