The marketing and use of Cardima’s Pathfinder and Revelation….
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Cardima Timeline July 1997 IDE approved Pathfinder Micro for AF mapping July 9, 1997
Two patients treated in beginning of Mapping Feasibility Study* excerpts toward the bottom of this pagehttp://www.accessdata.fda.gov/cdrh_docs/pdf/K971975.pdf July 1998
IDE approved for Pathfinder for diagnosis of VTac (mapping) April 3, 1998–
Berger feasibility study Pathfinder Ablation “the first patient in its (AF) ablation feasibility study was successfully treated last week.” 1998/99
Calkins Dog Studies Nov ’98 AHA Dallas: Ruskin announces Calkins dogs studies and Principal Investigator Dr. Jeremy Ruskin highlighted results from the recently completed AF feasibility ablation study in the United States consisting of 10 patients from Massachusetts General Hospital…. What study is this?Is it Berger with the Pathfinder?
According to Progress in catheter ablation: clinical application of new mapping … REVELATION was used in all ten patients
Feb 1, 2001431
Jan 31, 2001462
Dec 20, 2000327
Dec 19, 2000 Contract to sell patents to Medtronic
The REVELATION® family of catheters originated as mapping and pacing catheters
and evolved to include products that also had the capability of delivering RF energy
for ablation. The evolution of these products included some dimensional changes and
some electronic changes, such as the addition of thermocouples, but the product
materials and manufacturing process changed only minimally. In addition, the
REVELATION® family of products experienced a number of name changes (Table
1).
TABLE 1
REVELATION®/Pathfinder Product Name History
Original Name Regulatory Approval Second Name Current Name
Pathfinder 1.8mm, 2.5F K955802 (01/29/97) Pathfinder Pathfinder
Pathfinder 3mm, 3.3F K970853 (11/04/97) Pathfinder AF REVELATION
AF
Pathfinder 1mm, 1.5F K971975 (07/01/97) N/A Pathfinder Mini
Pathfinder AFTC Pending Pathfinder AFTC REVELATION®
Tx
_________________
6.2 Objectives
The purpose of the study was to assess the safety and effectiveness of the
REVELATION® Tx Microcatheter Ablation System in the treatment of subjects with
drug refractory paroxysmal AF by creating linear lesions with RF energy in the right
atrium.
Hugh Calkins, MD The Johns Hopkins Hospital ….
Patients treated by Calkins:
I (IIa) …. 4
II, III…… 6
