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SWAV

ShockWave Medical

$41.60

-0.52 (-1.23%)

08:33
09/03/19
09/03
08:33
09/03/19
08:33

ShockWave receives FDA breakthrough device designation for Coronary IVL System

Shockwave Medical announced that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which is currently the subject of an Investigational Device Exemption study called DISRUPT CAD III. The Shockwave C2 IVL Catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle. DISRUPT CAD III is a prospective, non-randomized, multicenter global IDE study to demonstrate the safety and effectiveness of the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting. The study is approved to enroll 442 patients at 50 centers in the United States and Europe, and is led by co-principal investigators Drs. Dean Kereiakes and Jonathan Hill. As reported in the company's second quarter earnings call, the study had enrolled 108 patients as of June 30, 2019. Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States.

  • 04

    Sep

  • 09

    Sep

SWAV ShockWave Medical
$41.60

-0.52 (-1.23%)

04/01/19
BOFA
04/01/19
INITIATION
Target $37
BOFA
Neutral
ShockWave Medical initiated with a Neutral at BofA/Merrill
BofA/Merrill analyst Bob Hopkins initiated ShockWave Medical with a Neutral and $37 price target citing valuation.
04/01/19
MSCO
04/01/19
INITIATION
Target $32
MSCO
Equal Weight
Morgan Stanley starts ShockWave Medical at Equal Weight, citing valuation
As previously reported, Morgan Stanley analyst David Lewis initiated ShockWave Medical with an Equal Weight rating, citing a valuation that he sees as reflecting a balance of the company's significant opportunity and the risks. While Shockwave is "a disruptive technology poised for rapid adoption," it is clear from the stock's performance since the IPO that investors have looked far into the future and shown great comfort in market development and physician adoption, said Lewis, who set a $32 price target on the shares.
04/01/19
WELS
04/01/19
INITIATION
Target $33
WELS
Market Perform
ShockWave Medical initiated with a Market Perform at Wells Fargo
Wells Fargo analyst Larry Biegelsen started coverage of ShockWave Medical with a Market Perform rating and a $33 price target. The analyst believes the company's intravascular lithotripsy is an innovative technology that has several key advantages over the competition, and that it will be able to both grow the market opportunity for calcium modification devices and take share from the atherectomy players. That stated, at current valuations, Biegelsen does not see the potential for meaningful multiple expansion.
06/18/19
ADAM
06/18/19
NO CHANGE
Target $65
ADAM
Buy
ShockWave Medical price target raised to $65 from $50 at Canaccord
Canaccord analyst Jason Mills raised his price target on ShockWave Medical to $65 from $50 as he remains bullish due to a myriad of positive updates on the firm's proprietary IVL platform. TAVR remains the company's largest near-term opportunity but as the technology has continually improved, the percentage of TAVR cases able to be performed via a transfemoral access route has increased. Mills reiterated his Buy rating on ShockWave Medical shares.

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