News Release Details
Shockwave Initiates Study of Coronary Intravascular Lithotripsy in Japan
The first CAD IV patient was enrolled earlier this week by the principal investigator of the study,
“We are honored to initiate the clinical investigation of coronary IVL in
Similar to the DISRUPT CAD III Study protocol, CAD IV will assess the absence of major adverse cardiac events (MACE) within 30 days of the index procedure as the primary safety endpoint. The primary effectiveness endpoint is procedural success, defined as stent delivery with a residual stenosis <50 percent, and without in-hospital MACE. Study enrollment is expected to be completed by
“Based on the interest, feedback and rapid adoption in other
Coronary artery calcium physically impairs stent expansioni and is perhaps the single most important predictor of early stent thrombosis and restenosis after stent procedures.ii, iii, iv Coronary IVL is a therapy designed to treat calcified artery blockages with sonic pressure waves historically used to treat patients with kidney stones. The technology seeks to minimize trauma within the artery by delivering pulsatile sonic pressure waves locally to fracture both intimal and medial calcium in the artery wall but pass through surrounding soft vascular tissue in a safe manner.
Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in
This press release may contain statements relating to Shockwave’s expectations, projections, beliefs, and prospects (including any statements regarding the future success, safety profile or commercialization of IVL and Shockwave’s ability to receive approval for, and begin commercializing, the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter in various geographies), which are “forward-looking statements” within the meaning of the federal securities laws and by their nature are uncertain. Words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plans,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability; failure to effectively market existing products; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; the inability to attain coverage and adequate reimbursement for procedures using our products; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission (
i Kobayashi Y, Okura H, Kume T, Yamada R, Kobayashi Y, Fukuhara K, Koyama T, Nezuo S, Neishi Y, Hayashida A, Kawamoto T, Yoshida K. Impact of target lesion coronary calcification on stent expansion. Circ J 2014;78:2209-2214.
ii Fitzgerald PJ, Oshima A, Hayase M, Metz JA, Bailey SR, Baim DS, Cleman MW, Deutsch E, Diver DJ, Leon MB, Moses JW, Oesterle SN, Overlie PA, Pepine CJ, Safian RD, Shani J, Simonton CA, Smalling RW, Teirstein PS, Zidar JP, Yeung AC, Kuntz RE, Yock PG. Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study. Circulation 2000;102:523-530.
iii Choi SY, Witzenbichler B, Maehara A, Lansky AJ, Guagliumi G, Brodie B, Kellett MA, Jr., Dressler O, Parise H, Mehran R, Dangas GD, Mintz GS, Stone GW. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) substudy. Circ Cardiovasc Interv 2011;4:239-247
iv Ahn JM, Kang SJ, Yoon SH, Park HW, Kang SM, Lee JY, Lee SW, Kim YH, Lee CW, Park SW, Mintz GS, Park SJ. Meta-analysis of outcomes after intravascular ultrasound-guided versus angiography-guided drug-eluting stent implantation in 26,503 patients enrolled in three randomized trials and 14 observational studies. Am J Cardiol 2014;113:1338-1347.
Source: Shockwave Medical, Inc.