FDA Clears Volcano Corp's iFR Modality - Analyst Blog

Precision-guided therapy tools provider Volcano Corporation VOLC recently received the U.S. Food and Drug Administration's (FDA) approval for the company's proprietary iFR (instant wave-Free Ratio) Modality. Subsequently, the company initiated the limited market release of the product in the U.S.

According to Volcano Corp., iFR Modality can be performed with the same pressure wires and equipment used for Fractional Flow Reserve FFR. However, it does not inject hyperemic agents into the patient's body that cause stress to the heart. Moreover, iFR reduces timing costs per procedure and makes physiology guidance fast and routine during multi-vessel disease cases. Combined with the company's recently-introduced Verrata Pressure Guide Wire, the iFR Modality can be used most efficiently.

The iFR Modality, which was earlier introduced in Europe and Japan, has shown a strong adoption rate. Currently, this product is installed on more than 300 systems globally, including Europe and Japan. According to the company, this latest U.S. FDA clearance will boost the adoption rate further leading to upgradation of more than 90% of Volcano's worldwide installed base of multi-modality systems.

Volcano Corp. is currently progressing well with the rollout of iFR Modality in Europe and Japan. According to the company, the recent release of two studies, ADVISE II and ADAPT-DES with their positive outcomes, will help increase iFR and FFR adoption and IVUS penetration in more complex cases.

According to the company, the broader market for intra-body imaging and sensing products is expected to grow from $332 million in 2006 to $2.7 billion by 2021, representing a CAGR of 15% approximately. Within this broader market, the current market for IVUS, FFR and Axsun products will capture only $750 million reflecting high growth potential in the coming period. We note that the current growth trend in the IVUS and FFR markets are impressive at approximately 3.5% and 20–30% respectively.

The stock currently carries a Zacks Rank #4 (Sell). Well-placed medical stocks worth considering include ABIOMED, Inc. ABMD, Cyberonics Inc. CYBX and DexCom, Inc. DXCM. All the three stocks hold a Zacks Rank #2 (Buy).