Replies to post #54 on Shockwave Medical Inc (SWAV)

[Whalatane]

Hi Rose . The only people using ShockWave Medical 's patented technology are interventionist Cardiologists ....and they have to be trained by ShockWave Medical before hand .

Do you have any updates on the PREPARE-IT trial . I haven't seen Pdude post on it recently ( unless I missed it )
thx
Kiwi

[Whalatane]

Rose ...new high today , Q1 earnings on May 10th .
Be interesting to see the order flow since the coronary application FDA approval .

Coronary Launch

The C2 System was approved by the U.S. Food and Drug Administration on February 12, 2021 for use in calcified de-novo coronary arteries prior to implanting a stent. Subsequent to FDA approval, the company has achieved the following results with C2 in the United States through March 29, 2021:

Shockwave territory managers have launched an average of just over 1.5 U.S. accounts per month, consistent with the company’s stated strategy of executing the launch in a disciplined and sustainable fashion.
C2 clinical performance in the U.S. has been consistent with Shockwave’s experience with C2 in international markets.
Over 120 U.S. customers have purchased the C2 Launch Kit, with initial launch orders averaging approximately six C2 units.
Nearly 50% of U.S. accounts that have initiated launch have completed the launch activities and are able to use IVL independently.
Five live cases utilizing C2 in U.S. centers have been performed in conjunction with the recent Cardiovascular Research Technologies (CRT) and Scottsdale Interventional Forum (SIF) Conferences.
Peripheral revenue in the U.S. has continued to grow month-over-month throughout the quarter.
First Quarter 2021

Kiwi

[Whalatane]

New Technology Add-on Payment (NTAP) Included in Proposed Fiscal Year 2022 Rule

SANTA CLARA, CALIF., April 27, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Centers for Medicare and Medicaid Services (CMS) published the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, which recommended that coronary IVL cases be eligible for incremental payment via a New Technology Add-On Payment (NTAP) from CMS when performed in the hospital inpatient setting. The proposed annual rule is now open for public comment and is expected to be finalized and in effect by October 1, 2021.

NTAP is a program designed by CMS to provide payment for qualifying new technologies in order to facilitate patient access to the new technology while CMS collects cost data. The NTAP program is intended to cover the majority of excess costs related to the new technology, though payment varies on a case-by-case basis. In its proposed ruling, CMS noted that coronary IVL is an FDA-designated Breakthrough Device that has met all the requirements for an NTAP and proposed that the maximum amount of NTAP payment for a procedure involving coronary IVL is an additional $3,666 to the hospital’s Medicare Severity Diagnosis Related Group (MS-DRG) payment.

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Kiwi