Heidelberg Engineering Receives FDA Clearance to Market SPECTRALIS® OCT Glaucoma Module Premium Edition

The Glaucoma Module Premium Edition adds diagnostic capabilities to
Heidelberg Engineering’s SPECTRALIS
® OCT
imaging platform. The module provides clinicians with several objective
and automated measurement parameters to deliver increased diagnostic
accuracy.


HEIDEBERG, Germany–(BUSINESS WIRE)–The Glaucoma Module Premium Edition for SPECTRALIS provides a
comprehensive analysis of the optic nerve head, retinal nerve fiber
layer, and ganglion cell layer by precisely matching unique scan
patterns to the fine anatomic structures relevant in glaucoma
diagnostics.

By means of a new proprietary technology called the Anatomic Positioning
System, the module creates an anatomic map unique to each patient’s eye
using two fixed, structural landmarks: the center of the fovea and the
center of Bruch’s membrane opening. All subsequent scan protocols are
automatically oriented according to each eye’s unique anatomic map,
enabling a precise examination of relevant structures over time.

Furthermore, the Glaucoma Module Premium Edition compares patients’ eyes
to an age- and disc size-adjusted reference database of healthy eyes
representing the racial and ethnic mix of the US population, flagging
small deviations that may be clinically relevant. This allows for a
highly sensitive assessment of structural damage characteristic of
glaucoma and a close monitoring of structural changes indicative of
glaucomatous progression.

The physiological and technical premise of the Glaucoma Module Premium
Edition is based on research collaborations between two groups led by
Balwantray C. Chauhan, Ph.D., Dalhousie University in Halifax (Canada),
and Claude F. Burgoyne, M.D., Devers Eye Institute in Portland, OR (USA)
performed with the SPECTRALIS imaging platform1,2,3,4,5,6.
Their work revealed the importance of making an anatomically and
geometrically accurate neuroretinal rim measurement using Bruch’s
membrane opening, the anatomical outer border of the rim.

“The measurements are more accurate because they are based on an
identifiable anatomical border of the rim and take into account its
varying geometry at the point of measurement”, said Dr. Burgoyne. Dr.
Chauhan added: “We have already been able to demonstrate that the use of
this new measurement method translates into significantly enhanced
diagnostic accuracy.”

“The 510(k) clearance of this product is great news for our company and
also for glaucoma patients in the U.S. The Glaucoma Module Premium
Edition is an excellent tool to assess glaucomatous damage based on a
novel objective examination of the optic nerve head anatomy”, summarizes
Dr. Gerhard Zinser, Managing Director of Heidelberg Engineering.

Analysis of the optic nerve head with Heidelberg Engineering’s
SPECTRALIS
® Glaucoma Module Premium Edition

References:

1. Chauhan B.C. et al., Ophthalmology, 2013;120:535–543.

2. Chauhan B.C. and Burgoyne C.F., Am J Ophthalmol. 2013;156:218-227.

3. Chauhan B.C. et al.,Ophthalmology, 2015;122:1786-1794.

4. He L. et al., PLoS One, 2014;9:e92225.

5. Reis A.S.et al., Ophthalmology, 2012;119:738–747.

6. Reis A.S. et al., Invest. Ophthalmol. Vis. Sci., 2012;53:1852–1860.

About Heidelberg Engineering:

Heidelberg Engineering is a high-tech imaging solutions company which
designs, manufactures, and distributes diagnostic instruments for eye
care professionals. The company’s products are used around the world by
ophthalmologists and optometrists to scan patients’ eyes for signs of
disease and to assist in the management of patients found to have
disease. Early recognition of disease helps to delay and prevent the
most common causes of blindness.

Typical diseases which can be recognized and tracked with Heidelberg
Engineering’s technology include glaucoma, age-related macular
degeneration, diabetic retinopathy, and macular edema.

The company’s core technologies include confocal microscopy, scanning
lasers and optics, optical coherence tomography, software image analysis
and IT solutions for image management.

Heidelberg Engineering is a privately held company, headquartered in
Heidelberg, Germany. The company distributes its products through a
network of wholly owned subsidiaries and distribution partners in most
countries of the world.

www.HeidelbergEngineering.com

Contacts

Heidelberg Engineering
Leticia Jimenez, +49 6221 64 63 317
Leticia.Jimenez@HeidelbergEngineering.com