LimFlow said today that it won an investigational device exemption from the FDA for a pivotal trial of its catheter-based intervention for a severe form of peripheral artery disease. LimFlow’s percutaneous deep vein arterialization device is designed to re-route blood flow from a blocked artery through the venous system to deliver oxygenated blood to the […]
LimFlow raises $34m in Series C round
LimFlow said today it raised $33.5 million (EU €27 million) in an oversubscribed Series C round of financing to support its technology designed to treat critical limb ischemia. The round was led by Sofinnova Partners and joined by existing investors BpiFrance and Balestier, the Paris-based company said. As part of the funding round, Sofinnova venture […]
LimFlow hopes to give end-stage CLI patients an alternative to amputation with its pDVA system
Earlier this year the FDA accepted LimFlow’s Percutaneous Deep Vein Arterialization system into its Breakthrough Device Program. CEO Dan Rose is hopeful that that designation, along with an increased feasibility study size, will help get the company’s pDVA product to critical limb ischemia patients in the US facing limb amputations with no other options. “There […]
Tricuspid repair firm 4Tech taps ex-Boston Scientific execs for CEO, CMO | Personnel Moves for Feb. 27, 2018
4Tech said last week that it named a pair of Boston Scientific (NYSE:BSX) veterans as its new CEO and CMO, with onetime chief Mike Ennen stepping away for “family reasons.” Galway, Ireland-based 4Tech said former Boston transcatheter aortic valve GM Tom Fleming is slated to take the reins from Thoratec vet Ennen as president & CEO in […]
LimFlow touts pDVA pilot trial data, technical success rate
LimFlow today released results from the pilot study of its LimFlow percutaneous deep vein arterialization system, touting that the trial met all its safety endpoints and had a technical success rate of 100%. The French company’s pDVA system is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations […]
LimFlow launches pDVA end-stage CLI treatment trial
LimFlow said today it launched a US feasibility study of its LimFlow percutaneous deep vein arterialization system designed for treating end-stage clinical limb ischemia. LimFlow’s pDVA system is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations and restore mobility. The system uses ultrasound-guided catheters and covered nitinol […]
Avita Medical taps ex-Novartis exec Perry for CEO as it shifts focus to US | Personnel Moves June 9, 2017
Avita Medical (ASX:AVH) said last week it tapped former Novartis (NYSE:NVS) global biz dev & licensing chief scientific officer Dr. Michael Perry as its new chief executive officer, replacing resigning CEO Adam Kelliher. Dr. Perry served as a non-exec director of Avita since Feb 2013, according to the company, and held positions with Novartis including chief scientific […]
LimFlow wins FDA IDE to launch end-stage CLI treatment trial
LimFlow said today it won FDA investigational device exemption to launch a feasibility study of its LimFlow percutaneous deep vein arterialization system in patients with end-stage critical limb ischemia. The company said that the study will examine the use of its system in treating CLI patients facing major amputations. The system is designed to bypass blocked […]
LimFlow wins CE Mark for PAD device
LimFlow said today it won CE Mark approval in the European Union for its percutaneous LimFlow system designed for venous arterialization of the lower limbs for peripheral artery disease patients. The company said the device is designed to promote chronic wound healing and avoid major amputation using proprietary ultrasound guided catheters and nitinol stents to […]
LimFlow taps Rose for CEO | Personnel Moves
LimFlow taps ex-Direct Flow GM Rose as CEO LimFlow said this week that it tapped former Direct Flow Medical VP and GM Daniel Rose as its new chief executive, with former co-founder & CEO Timothy Lenihan transitioning to chief technology officer. LimFlow is developing a device to create percutaneous venous arterialization in the foot to treat end-stage critical limb […]
Medtronic, LivaNova get in on $12m round for European medtech incubator MD Start
A European medical device incubator said yesterday that it raised nearly $12 million from backers including Medtronic (NYSE:MDT) and LivaNova (NSDQ:LIVN). Paris-based MD Start invested in 3 companies using its 1st fund and has already invested in a 4th from the just-announced $11.5 million fund, which was led by French public investment bank Bpifrance and included Sofinnova Partners. “MD Start II […]
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